Role of Endomyocardial Biopsy and Aetiology-based Treatment in Patients With Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management

NCT04521790 | Recruiting

• 1 other identifier: MYOCAR
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Myocarditis is a complex inflammatory disease, usually occurring secondary to viral infections, autoimmune processes or toxic agents. Clinical presentations are multiple, including chest-pain, heart failure and a broad spectrum of arrhythmias. In turn, outcome is largely unpredictable, ranging from mild self-limiting disease, to chronic stage and progressive evolution towards dilated cardiomyopathy, to rapid adverse outcome in fulminant forms. Subsequently, myocarditis is often underdiagnosed and undertreated, and optimal diagnostic and therapeutic strategies are still to be defined. This study, both retrospective and prospective, originally single-center and subsequently upgraded to multicenter, aims at answering multiple questions about myocarditis, with special attention to its arrhythmic manifestations.

1. 1.Optimal diagnostic workflow is still to be defined. In fact, although endomyocardial biopsy (EMB) is still the diagnostic gold standard, especially for aetiology identification, it is an invasive technique. Furthermore, it may lack sensitivity because of sampling errors. By converse, modern imaging techniques - cardiac magnetic resonance (CMR) in particular - have been proposed as alternative or complementary diagnostic tool in inflammatory heart disease. Other noninvasive diagnostic techniques, like delayed-enhanced CT (DECT) scan or position emission tomography (PET) scan, are under investigation.
2. 2.Biomarkers to identify myocarditis aetiology, predisposition, prognosis and response to treatment are still to be defined.
3. 3.Arrhythmic myocarditis is largely underdiagnosed and uninvestigated. Importantly, myocarditis presenting with arrhythmias requires specific diagnostic, prognostic and therapeutic considerations. At the group leader hospital, which is an international referral center for ventricular arrhythmias management and ablation, a relevant number of patients with unexplained arrhythmias had myocarditis as underlying aetiology. The experience of a dedicated third-level center is going to be shared with other centers, to considerably improve knowledge and management of arrhythmic myocarditis.
4. 4.The role of CMR, as well as alternative noninvasive imaging techniques, in defining myocarditis healing is a relevant issue. In particular, optimal timing for follow-up diagnostic reassessment is still to be defined, in patients with myocarditis at different inflammatory stages, either with or without aetiology-dependent treatment.
5. 5.Uniformly-designed studies are lacking, to compare myocarditis among different patient subgroups, differing by variables like: clinical presentations, myocarditis stage, associated cardiac or extra-cardiac diseases, aetiology-based treatment, associated arrhythmic manifestations, diagnostic workup, and devices or ablation treatment.

Conditions

Myocarditis; Ventricular Arrythmia; Inflammatory Cardiomyopathy; Genetic Predisposition; Autoimmunity; Arrhythmia; Cardiomyopathies; Immunosuppression; Catheter Ablation

Keywords

Myocarditis; Ventricular arrhythmias; Arrhythmias; Arrhythmogenic inflammatory cardiomyopathy; Endomyocardial biopsy; Cardiac magnetic resonance; Ablation; Positron emission tomography; Cardiac imaging; Electroanatomical mapping; Immunosuppressive therapy; Arrhythmic risk stratification; Genetic predisposition; Environment; Implantable cardioverter defibrillator; Implantable loop recorder; Multicenter

Outcome Measures

Primary Outcomes (69)

• Occurrence of major cardiac events

  death; cardiac death; malignant ventricular arrhythmias ( = VT, VF, appropriate ICD therapy); heart transplantation; end-stage heart failure

  By 12-month follow-up

• Occurrence of major cardiac events

  death; cardiac death; malignant ventricular arrhythmias ( = VT, VF, appropriate ICD therapy); heart transplantation; end-stage heart failure

  By 24-month follow-up

• Occurrence of major cardiac events

  death; cardiac death; malignant ventricular arrhythmias ( = VT, VF, appropriate ICD therapy); heart transplantation; end-stage heart failure

  By 3-year follow-up

• Occurrence of major cardiac events

  death; cardiac death; malignant ventricular arrhythmias ( = VT, VF, appropriate ICD therapy); heart transplantation; end-stage heart failure

  By 5-year follow-up

• Occurrence of major cardiac events

  death; cardiac death; malignant ventricular arrhythmias ( = VT, VF, appropriate ICD therapy); heart transplantation; end-stage heart failure

  By 7-year follow-up

• Occurrence of major cardiac events

  death; cardiac death; malignant ventricular arrhythmias ( = VT, VF, appropriate ICD therapy); heart transplantation; end-stage heart failure

  By 10-year follow-up

• Assessment of diagnostic accuracy (in terms of true/false positive/negative rates) between EMB and second level imaging findings - Primary

  Diagnostic concordance in terms of sensitivity, specificity, positive predictive value, negative predictive value

  At baseline assessment

• Assessment of diagnostic accuracy (in terms of true/false positive/negative rates) between EMB and second level imaging findings - Primary

  Diagnostic concordance in terms of sensitivity, specificity, positive predictive value, negative predictive value

  By 6-month follow-up

• Assessment of diagnostic accuracy (in terms of true/false positive/negative rates) between EMB and second level imaging findings - Primary

  Diagnostic concordance in terms of sensitivity, specificity, positive predictive value, negative predictive value

  By 12-month follow-up

• Assessment of diagnostic accuracy (in terms of true/false positive/negative rates) between EMB and second level imaging findings - Primary

  Diagnostic concordance in terms of sensitivity, specificity, positive predictive value, negative predictive value

  By 24-month follow-up

• Assessment of diagnostic accuracy (in terms of true/false positive/negative rates) between EMB and second level imaging findings - Primary

  Diagnostic concordance in terms of sensitivity, specificity, positive predictive value, negative predictive value

  By 3-year follow-up

• Assessment of diagnostic accuracy (in terms of true/false positive/negative rates) between EMB and second level imaging findings - Primary

  Diagnostic concordance in terms of sensitivity, specificity, positive predictive value, negative predictive value

  By 5-year follow-up

• Assessment of diagnostic accuracy (in terms of true/false positive/negative rates) between EMB and second level imaging findings - Primary

  Diagnostic concordance in terms of sensitivity, specificity, positive predictive value, negative predictive value

  By 10-year follow-up

• Comparison of troponin values in patients with different aetiologies

  Measurement of troponin blood concentration (ng/l) and comparison of values found in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  At baseline assessment

• Description of troponin values changes during follow-up

  Measurement of troponin blood concentration (ng/l) during follow-up, and description of its relative variation compared to baseline assessment.

  By 10-year follow-up

• Comparison of creatine-phosphokinase values in patients with different aetiologies

  Measurement of creatine-phosphokinase (U/l) and comparison of values found in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  At baseline assessment

• Description of creatine-phosphokinase values changes during follow-up

  Measurement of creatine-phosphokinase (U/l) during follow-up, and description of its relative variation compared to baseline assessment.

  By 10-year follow-up

• Comparison of natriuretic peptides values in patients with different aetiologies

  Measurement of natriuretic peptides (pg/ml) and comparison of values found in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  At baseline assessment

• Description of natriuretic peptides values changes during follow-up

  Measurement of natriuretic peptides (pg/ml) during follow-up, and description of its relative variation compared to baseline assessment.

  By 10-year follow-up

• Comparison of C-reactive protein values in patients with different aetiologies

  Measurement of C-reactive protein (mg/l) and comparison of values found in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  At baseline assessment

• Description of C-reactive protein values changes during follow-up

  Measurement of C-reactive protein (mg/l) during follow-up, and description of its relative variation compared to baseline assessment.

  By 10-year follow-up

• Comparison of erythrocyte sedimentation rate values in patients with different aetiologies

  Measurement of erythrocyte sedimentation rate (mm/h) and comparison of values found in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  At baseline assessment

• Description of erythrocyte sedimentation rate values changes during follow-up

  Measurement of erythrocyte sedimentation rate (mm/h) during follow-up, and description of its relative variation compared to baseline assessment.

  By 10-year follow-up

• Comparison of procalcitonin values in patients with different aetiologies

  Measurement of procalcitonin (mcg/ml) and comparison of values found in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  At baseline assessment

• Comparison of procalcitonin values in patients with different aetiologies

  Measurement of procalcitonin (mcg/ml) and comparison of values found in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  By 10-year follow-up

• Comparison of serum uric acid values in patients with different aetiologies

  Measurement of serum uric acid (mg/dl) and comparison of values found in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  At baseline assessment

• Comparison of serum uric acid values in patients with different aetiologies

  Measurement of serum uric acid (mg/dl) and comparison of values found in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  By 10-year follow-up

• Comparison of leukocyte values in patients with different aetiologies

  Measurement of leukocytes (U/ml) in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  At baseline assessment

• Comparison of leukocyte values in patients with different aetiologies

  Measurement of leukocytes (U/ml) in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  By 10-year follow-up

• Comparison of hemoglobin values in patients with different aetiologies

  Measurement of hemoglobin (g/dl) in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  At baseline assessment

• Comparison of hemoglobin values in patients with different aetiologies

  Measurement of hemoglobin (g/dl) in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  By 10-year follow-up

• Comparison of platelet values in patients with different aetiologies

  Measurement of platelets (U/ml) in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  At baseline assessment

• Comparison of platelet values in patients with different aetiologies

  Measurement of platelets (U/ml) in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  By 10-year follow-up

• Comparison of thyroid function in patients with different aetiologies

  Measurement of thyroid stimulating hormone (mU/ml; total and fractions) in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  At baseline assessment

• Comparison of thyroid function in patients with different aetiologies

  Measurement of thyroid stimulating hormone (mU/ml; total and fractions) in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  By 10-year follow-up

• Comparison of organ damage in patients with different aetiologies

  Measurement of organ damage by application of the Sequential Organ Failure Assessment (SOFA) score in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  At baseline assessment

• Comparison of organ damage in patients with different aetiologies

  Measurement of organ damage by application of the Sequential Organ Failure Assessment (SOFA) score in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  By 10-year follow-up

• Reporting the results of autoimmunity screening

  Measurement of circulating autoantibodies (U/ml) in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  At baseline assessment

• Reporting the results of autoimmunity screening

  Measurement of circulating autoantibodies (U/ml) in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  By 10-year follow-up

• Reporting the results of infectious screening

  Measurement of viral antibodies (U/ml) in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  At baseline assessment

• Reporting the results of infectious screening

  Measurement of viral antibodies (U/ml) in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  By 10-year follow-up

• Reporting the results of toxicology screening

  Measurement of toxic urynalisis (U/ml) in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  At baseline assessment

• Reporting the results of toxicology screening

  Measurement of toxic urynalisis (U/ml) in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  By 10-year follow-up

• Reporting the results of genetic test screening

  Reporting the results of next generation sequencing analysis (mutation type) in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  At baseline assessment

• Reporting the results of genetic test screening

  Reporting the results of next generation sequencing analysis (mutation type) in patients with different aetiologies (viral; autoimmune; toxic; non-myocarditis).

  By 10-year follow-up

• Validation of optimal management of arrhythmic myocarditis by comparing the occurrence of major cardiac events in patients undergoing different therapeutic strategies - Primary

  Evaluation of the occurrence of major cardiac events (death; cardiac death; malignant ventricular arrhythmias= VT, VF, appropriate ICD therapy; heart transplantation; end-stage heart failure) in patient groups differing for: 1-General cardiac treatment. 2-Specific aetiology-driven treatment. 3-Cardiac device implant. 4-Arrhythmia ablation.

  By 10-year follow-up

• Validation of optimal management of arrhythmic myocarditis by comparing the occurrence of major cardiac events in patients undergoing different therapeutic strategies - Primary

  Evaluation of the occurrence of major cardiac events (death; cardiac death; malignant ventricular arrhythmias= VT, VF, appropriate ICD therapy; heart transplantation; end-stage heart failure) in patient groups differing for: 1-General cardiac treatment. 2-Specific aetiology-driven treatment. 3-Cardiac device implant. 4-Arrhythmia ablation.

  By 12-month follow-up

• Validation of optimal management of arrhythmic myocarditis by comparing the occurrence of major cardiac events in patients undergoing different therapeutic strategies - Primary

  Evaluation of the occurrence of major cardiac events (death; cardiac death; malignant ventricular arrhythmias= VT, VF, appropriate ICD therapy; heart transplantation; end-stage heart failure) in patient groups differing for: 1-General cardiac treatment. 2-Specific aetiology-driven treatment. 3-Cardiac device implant. 4-Arrhythmia ablation.

  By 24-month follow-up

• Validation of optimal management of arrhythmic myocarditis by comparing the occurrence of major cardiac events in patients undergoing different therapeutic strategies - Primary

  Evaluation of the occurrence of major cardiac events (death; cardiac death; malignant ventricular arrhythmias= VT, VF, appropriate ICD therapy; heart transplantation; end-stage heart failure) in patient groups differing for: 1-General cardiac treatment. 2-Specific aetiology-driven treatment. 3-Cardiac device implant. 4-Arrhythmia ablation.

  By 3-year follow-up

• Validation of optimal management of arrhythmic myocarditis by comparing the occurrence of major cardiac events in patients undergoing different therapeutic strategies - Primary

  Evaluation of the occurrence of major cardiac events (death; cardiac death; malignant ventricular arrhythmias= VT, VF, appropriate ICD therapy; heart transplantation; end-stage heart failure) in patient groups differing for: 1-General cardiac treatment. 2-Specific aetiology-driven treatment. 3-Cardiac device implant. 4-Arrhythmia ablation.

  By 5-year follow-up

• Validation of optimal management of arrhythmic myocarditis by comparing the occurrence of major cardiac events in patients undergoing different therapeutic strategies - Primary

  Evaluation of the occurrence of major cardiac events (death; cardiac death; malignant ventricular arrhythmias= VT, VF, appropriate ICD therapy; heart transplantation; end-stage heart failure) in patient groups differing for: 1-General cardiac treatment. 2-Specific aetiology-driven treatment. 3-Cardiac device implant. 4-Arrhythmia ablation.

  By 7-year follow-up

• Evaluation of healing timing in myocarditis - Primary

  Any degree of recovery through analysis of CMR, other second level imaging, echocardiogram, cardiac and inflammatory biomarkers, symptoms, arrhythmia burden, and exercise tolerance.

  By 1-month follow-up

• Evaluation of healing timing in myocarditis - Primary

  Any degree of recovery through analysis of CMR, other second level imaging, echocardiogram, cardiac and inflammatory biomarkers, symptoms, arrhythmia burden, and exercise tolerance.

  By 3-month follow-up

• Evaluation of healing timing in myocarditis - Primary

  Any degree of recovery through analysis of CMR, other second level imaging, echocardiogram, cardiac and inflammatory biomarkers, symptoms, arrhythmia burden, and exercise tolerance.

  By 6-month follow-up

• Evaluation of healing timing in myocarditis - Primary

  Any degree of recovery through analysis of CMR, other second level imaging, echocardiogram, cardiac and inflammatory biomarkers, symptoms, arrhythmia burden, and exercise tolerance.

  By 9-month follow-up

• Evaluation of healing timing in myocarditis - Primary

  Any degree of recovery through analysis of CMR, other second level imaging, echocardiogram, cardiac and inflammatory biomarkers, symptoms, arrhythmia burden, and exercise tolerance.

  By 12-month follow-up

• Evaluation of healing timing in myocarditis - Primary

  Any degree of recovery through analysis of CMR, other second level imaging, echocardiogram, cardiac and inflammatory biomarkers, symptoms, arrhythmia burden, and exercise tolerance.

  By 18-month follow-up

• Evaluation of healing timing in myocarditis - Primary

  Any degree of recovery through analysis of CMR, other second level imaging, echocardiogram, cardiac and inflammatory biomarkers, symptoms, arrhythmia burden, and exercise tolerance.

  By 24-month follow-up

• Evaluation of healing timing in myocarditis - Primary

  Any degree of recovery through analysis of CMR, other second level imaging, echocardiogram, cardiac and inflammatory biomarkers, symptoms, arrhythmia burden, and exercise tolerance.

  By 3-year follow-up

• Evaluation of healing timing in myocarditis - Primary

  Any degree of recovery through analysis of CMR, other second level imaging, echocardiogram, cardiac and inflammatory biomarkers, symptoms, arrhythmia burden, and exercise tolerance.

  By 5-year follow-up

• Evaluation of healing timing in myocarditis - Primary

  Any degree of recovery through analysis of CMR, other second level imaging, echocardiogram, cardiac and inflammatory biomarkers, symptoms, arrhythmia burden, and exercise tolerance.

  By 7-year follow-up

• Evaluation of healing timing in myocarditis - Primary

  Any degree of recovery through analysis of CMR, other second level imaging, echocardiogram, cardiac and inflammatory biomarkers, symptoms, arrhythmia burden, and exercise tolerance.

  By 10-year follow-up

• Comparison of the incidence of major cardiac events in different patient subgroups - Primary

  Evaluation of the occurrence of major cardiac events (death; cardiac death; malignant ventricular arrhythmias= VT, VF, appropriate ICD therapy; heart transplantation; end-stage heart failure) in different patient groups: A. Arrhythmic myocarditis subgroups (1-4). B. Non-arrhythmic myocarditis subgroups (i.e.: fulminant, acute coronary syndrome-like, pericarditis-like, heart failure, nonischaemic dilated /hypokinetic cardiomyopathies of unknown aetiology…). C.Infectious vs. autoimmune vs. toxic myocarditis. D.Myocarditis treated by aetiology-based treatment vs. isolated cardiac medical treatment. E.Myocarditis at different disease stages: acute, hyperacute, fulminant, chronic active, post-inflammatory, or active vs. previous vs. non-myocarditis. F. Myocarditis presenting as organ-specific diseases vs. in the context of a genetic disorder or systemic disease. G.Myocarditis vs. peri-myocarditis/myo-pericarditis. H.Other subgroups.

  At baseline assessment

• Comparison of the incidence of major cardiac events in different patient subgroups - Primary

  Evaluation of the occurrence of major cardiac events (death; cardiac death; malignant ventricular arrhythmias= VT, VF, appropriate ICD therapy; heart transplantation; end-stage heart failure) in different patient groups: A. Arrhythmic myocarditis subgroups (1-4). B. Non-arrhythmic myocarditis subgroups (i.e.: fulminant, acute coronary syndrome-like, pericarditis-like, heart failure, nonischaemic dilated /hypokinetic cardiomyopathies of unknown aetiology…). C.Infectious vs. autoimmune vs. toxic myocarditis. D.Myocarditis treated by aetiology-based treatment vs. isolated cardiac medical treatment. E.Myocarditis at different disease stages: acute, hyperacute, fulminant, chronic active, post-inflammatory, or active vs. previous vs. non-myocarditis. F. Myocarditis presenting as organ-specific diseases vs. in the context of a genetic disorder or systemic disease. G.Myocarditis vs. peri-myocarditis/myo-pericarditis. H.Other subgroups.

  By 12-month follow-up

• Comparison of the incidence of major cardiac events in different patient subgroups - Primary

  Evaluation of the occurrence of major cardiac events (death; cardiac death; malignant ventricular arrhythmias= VT, VF, appropriate ICD therapy; heart transplantation; end-stage heart failure) in different patient groups: A. Arrhythmic myocarditis subgroups (1-4). B. Non-arrhythmic myocarditis subgroups (i.e.: fulminant, acute coronary syndrome-like, pericarditis-like, heart failure, nonischaemic dilated /hypokinetic cardiomyopathies of unknown aetiology…). C.Infectious vs. autoimmune vs. toxic myocarditis. D.Myocarditis treated by aetiology-based treatment vs. isolated cardiac medical treatment. E.Myocarditis at different disease stages: acute, hyperacute, fulminant, chronic active, post-inflammatory, or active vs. previous vs. non-myocarditis. F. Myocarditis presenting as organ-specific diseases vs. in the context of a genetic disorder or systemic disease. G.Myocarditis vs. peri-myocarditis/myo-pericarditis. H.Other subgroups.

  By 24-month follow-up

• Comparison of the incidence of major cardiac events in different patient subgroups - Primary

  Evaluation of the occurrence of major cardiac events (death; cardiac death; malignant ventricular arrhythmias= VT, VF, appropriate ICD therapy; heart transplantation; end-stage heart failure) in different patient groups: A. Arrhythmic myocarditis subgroups (1-4). B. Non-arrhythmic myocarditis subgroups (i.e.: fulminant, acute coronary syndrome-like, pericarditis-like, heart failure, nonischaemic dilated /hypokinetic cardiomyopathies of unknown aetiology…). C.Infectious vs. autoimmune vs. toxic myocarditis. D.Myocarditis treated by aetiology-based treatment vs. isolated cardiac medical treatment. E.Myocarditis at different disease stages: acute, hyperacute, fulminant, chronic active, post-inflammatory, or active vs. previous vs. non-myocarditis. F. Myocarditis presenting as organ-specific diseases vs. in the context of a genetic disorder or systemic disease. G.Myocarditis vs. peri-myocarditis/myo-pericarditis. H.Other subgroups.

  By 3-year follow-up

• Comparison of the incidence of major cardiac events in different patient subgroups - Primary

  Evaluation of the occurrence of major cardiac events (death; cardiac death; malignant ventricular arrhythmias= VT, VF, appropriate ICD therapy; heart transplantation; end-stage heart failure) in different patient groups: A. Arrhythmic myocarditis subgroups (1-4). B. Non-arrhythmic myocarditis subgroups (i.e.: fulminant, acute coronary syndrome-like, pericarditis-like, heart failure, nonischaemic dilated /hypokinetic cardiomyopathies of unknown aetiology…). C.Infectious vs. autoimmune vs. toxic myocarditis. D.Myocarditis treated by aetiology-based treatment vs. isolated cardiac medical treatment. E.Myocarditis at different disease stages: acute, hyperacute, fulminant, chronic active, post-inflammatory, or active vs. previous vs. non-myocarditis. F. Myocarditis presenting as organ-specific diseases vs. in the context of a genetic disorder or systemic disease. G.Myocarditis vs. peri-myocarditis/myo-pericarditis. H.Other subgroups.

  By 5-year follow-up

• Comparison of the incidence of major cardiac events in different patient subgroups - Primary

  Evaluation of the occurrence of major cardiac events (death; cardiac death; malignant ventricular arrhythmias= VT, VF, appropriate ICD therapy; heart transplantation; end-stage heart failure) in different patient groups: A. Arrhythmic myocarditis subgroups (1-4). B. Non-arrhythmic myocarditis subgroups (i.e.: fulminant, acute coronary syndrome-like, pericarditis-like, heart failure, nonischaemic dilated /hypokinetic cardiomyopathies of unknown aetiology…). C.Infectious vs. autoimmune vs. toxic myocarditis. D.Myocarditis treated by aetiology-based treatment vs. isolated cardiac medical treatment. E.Myocarditis at different disease stages: acute, hyperacute, fulminant, chronic active, post-inflammatory, or active vs. previous vs. non-myocarditis. F. Myocarditis presenting as organ-specific diseases vs. in the context of a genetic disorder or systemic disease. G.Myocarditis vs. peri-myocarditis/myo-pericarditis. H.Other subgroups.

  By 7-year follow-up

• Comparison of the incidence of major cardiac events in different patient subgroups - Primary

  Evaluation of the occurrence of major cardiac events (death; cardiac death; malignant ventricular arrhythmias= VT, VF, appropriate ICD therapy; heart transplantation; end-stage heart failure) in different patient groups: A. Arrhythmic myocarditis subgroups (1-4). B. Non-arrhythmic myocarditis subgroups (i.e.: fulminant, acute coronary syndrome-like, pericarditis-like, heart failure, nonischaemic dilated /hypokinetic cardiomyopathies of unknown aetiology…). C.Infectious vs. autoimmune vs. toxic myocarditis. D.Myocarditis treated by aetiology-based treatment vs. isolated cardiac medical treatment. E.Myocarditis at different disease stages: acute, hyperacute, fulminant, chronic active, post-inflammatory, or active vs. previous vs. non-myocarditis. F. Myocarditis presenting as organ-specific diseases vs. in the context of a genetic disorder or systemic disease. G.Myocarditis vs. peri-myocarditis/myo-pericarditis. H.Other subgroups.

  By 10-year follow-up

Secondary Outcomes (105)

• Occurrence of minor arrhythmic events

  At baseline assessment and through study completion (up to 10 years)

• Any modification in imaging parameters

  At baseline assessment and through study completion (up to 10 years)

• Any modification in clinical parameters

  By 10-year follow-up

• Any modification in New York Heart Association class

  By 10-year follow-up

• Any modification in exercise peak heart rate

  By 10-year follow-up

Study Arms (3)

Arrhythmic (A)

Arrhythmic Group. To oversimplify, specific subgroups of patients will be considered. 1. Group 1: major ventricular arrhythmias (haemodynamically unstable VT, hu-VT; ventricular fibrillation, VF). 2. Group 2: other ventricular arrhythmias (high-burden premature ventricular complexes = hb-PVC; nonsustained VT = NSVT; haemodynamically stable VT = hs-VT). 3. Group 3: bradyarrhythmias (2nd type II or 3rd degree atrioventricular block = advanced AVB; critical sinus pauses = SND). 4. Group 4: supraventricular arrhythmias (atrial fibrillation = AF; atrial flutter = AFlu; atrial tachycardia = AT).

Other: support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation

Nonarrhythmic (NA)

Nonarrhythmic Group. To oversimplify, specific subgroups of patients will be considered. 1. Heart failure presentation (and subtypes) 2. Chest pain presentation (and subtypes) 3. Asymptomatic presentation/screening (and subtypes)

Other: support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation

Subgroups

For specific study aims, different patient subgroups will be compared. The main groups are hereby reported: A. Arrhythmic myocarditis subgroups (1-4). B. Non-arrhythmic myocarditis subgroups (i.e.: fulminant, acute coronary syndrome-like, pericarditis-like, heart failure, nonischaemic dilated /hypokinetic cardiomyopathies of unknown aetiology…). C. Infectious vs. autoimmune vs. toxic myocarditis. D. Myocarditis treated by aetiology-based treatment vs. isolated cardiac medical treatment. E. Myocarditis at different disease stages: acute, hyperacute, fulminant, chronic active, post-inflammatory, or active vs. previous vs. non-myocarditis. F. Myocarditis presenting as organ-specific diseases vs. in the context of a genetic disorder or systemic disease. G. Myocarditis vs. peri-myocarditis/myo-pericarditis. H. Other subgroups.

Other: support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation

Interventions

support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation OTHER

Treatment will be patient-tailored, integrating international guidelines recommendation and the experience of the center where enrollment takes place.

Arrhythmic (A); Nonarrhythmic (NA); Subgroups

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will enroll adult patients (age ≥ 18 y), of any gender or ethnic group, evaulated for clinically suspected myocarditis. Patients can be enrolled from any medical environment or department, including inpatients, outpatients, and patients transferred from other hospitals. The same inclusion criteria of the original single-center protocol will apply to the entire multicenter study.

You may qualify if:

• Written informed consent.
• Age ≥ 18 years.
• Clinically suspected myocarditis.
• Enrollment performed by one of the participating Centers.

You may not qualify if:

• Absence of written informed consent.
• Age \< 18 years (paediatric population).

Sponsors & Collaborators

• Scientific Institute San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele Scientific Institute

Milan, Milano, 20132, Italy

RECRUITING

Related Publications (40)

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• De Luca G, Campochiaro C, Franchini S, Sartorelli S, Candela C, Peretto G, Sala S, Dagna L. Unexpected acute lymphocytic virus-negative myocarditis in a patient with limited cutaneous systemic sclerosis: a case report. Scand J Rheumatol. 2019 Mar;48(2):166-167. doi: 10.1080/03009742.2018.1493744. Epub 2018 Sep 30. No abstract available.

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• Peretto G, Sala S, Rizzo S, De Luca G, Campochiaro C, Sartorelli S, Benedetti G, Palmisano A, Esposito A, Tresoldi M, Thiene G, Basso C, Della Bella P. Arrhythmias in myocarditis: State of the art. Heart Rhythm. 2019 May;16(5):793-801. doi: 10.1016/j.hrthm.2018.11.024. Epub 2018 Nov 24.

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• Peretto G, Sala S, De Luca G, Campochiaro C, Sartorelli S, Cappelletti AM, Rizzo S, Palmisano A, Esposito A, Margonato A, Tresoldi M, Thiene G, Basso C, Dagna L, Della Bella P. Impact of systemic immune-mediated diseases on clinical features and prognosis of patients with biopsy-proved myocarditis. Int J Cardiol. 2019 Apr 1;280:110-116. doi: 10.1016/j.ijcard.2018.11.104. Epub 2018 Nov 22.

  PMID: 30522885 RESULT

• Sartorelli S, De Luca G, Campochiaro C, Peretto G, Sala S, Esposito A, Busnardo E, Basso C, Thiene G, Dagna L. Successful use of sirolimus in a patient with cardiac microangiopathy in primary antiphospholipid syndrome. Scand J Rheumatol. 2019 Nov;48(6):515-516. doi: 10.1080/03009742.2019.1574022. Epub 2019 Feb 22. No abstract available.

  PMID: 30794015 RESULT

• Gatti M, Palmisano A, Faletti R, Benedetti G, Bergamasco L, Bioletto F, Peretto G, Sala S, De Cobelli F, Fonio P, Esposito A. Two-dimensional and three-dimensional cardiac magnetic resonance feature-tracking myocardial strain analysis in acute myocarditis patients with preserved ejection fraction. Int J Cardiovasc Imaging. 2019 Jun;35(6):1101-1109. doi: 10.1007/s10554-019-01588-8. Epub 2019 Mar 30.

  PMID: 30929101 RESULT

• De Luca G, Campochiaro C, Sartorelli S, Peretto G, Sala S, Palmisano A, Esposito A, Candela C, Basso C, Rizzo S, Thiene G, Della Bella P, Dagna L. Efficacy and safety of mycophenolate mofetil in patients with virus-negative lymphocytic myocarditis: A prospective cohort study. J Autoimmun. 2020 Jan;106:102330. doi: 10.1016/j.jaut.2019.102330. Epub 2019 Sep 3.

  PMID: 31488318 RESULT

• Peretto G, Basso C, Bella PD, Sala S. Thyroid dysfunction in adult patients with biopsy-proved myocarditis: Screening and characterization. Eur J Intern Med. 2020 Jan;71:98-100. doi: 10.1016/j.ejim.2019.11.008. Epub 2019 Nov 14. No abstract available.

  PMID: 31733987 RESULT

• Campochiaro C, De Luca G, Tomelleri A, Sartorelli S, Peretto G, Sala S, Palmisano A, Esposito A, Cavalli G, Dagna L. Tocilizumab for the Treatment of Myocardial Inflammation Shown by Cardiac Magnetic Resonance: Report of Two Cases and Rationale for Its Therapeutic Use. J Clin Rheumatol. 2021 Dec 1;27(8S):S476-S479. doi: 10.1097/RHU.0000000000001194. No abstract available.

  PMID: 31790000 RESULT

• De Luca G, Campochiaro C, De Santis M, Sartorelli S, Peretto G, Sala S, Canestrari G, De Lorenzis E, Basso C, Rizzo S, Thiene G, Palmisano A, Esposito A, Selmi C, Gremese E, Della Bella P, Dagna L, Bosello SL. Systemic sclerosis myocarditis has unique clinical, histological and prognostic features: a comparative histological analysis. Rheumatology (Oxford). 2020 Sep 1;59(9):2523-2533. doi: 10.1093/rheumatology/kez658.

  PMID: 31990340 RESULT

• Peretto G, Sala S, Basso C, Della Bella P. Programmed ventricular stimulation in patients with active vs previous arrhythmic myocarditis. J Cardiovasc Electrophysiol. 2020 Mar;31(3):692-701. doi: 10.1111/jce.14374. Epub 2020 Feb 3.

  PMID: 31999020 RESULT

• Peretto G, Sala S, Della Bella P. [Diagnostic and therapeutic approach to myocarditis patients presenting with arrhythmias]. G Ital Cardiol (Rome). 2020 Mar;21(3):187-194. doi: 10.1714/3306.32767. Italian.

  PMID: 32100731 RESULT

• Peretto G, Sala S, Rizzo S, Palmisano A, Esposito A, De Cobelli F, Campochiaro C, De Luca G, Foppoli L, Dagna L, Thiene G, Basso C, Della Bella P. Ventricular Arrhythmias in Myocarditis: Characterization and Relationships With Myocardial Inflammation. J Am Coll Cardiol. 2020 Mar 10;75(9):1046-1057. doi: 10.1016/j.jacc.2020.01.036.

  PMID: 32138965 RESULT

• Palmisano A, Benedetti G, Faletti R, Rancoita PMV, Gatti M, Peretto G, Sala S, Boccia E, Francone M, Galea N, Basso C, Del Maschio A, De Cobelli F, Esposito A. Early T1 Myocardial MRI Mapping: Value in Detecting Myocardial Hyperemia in Acute Myocarditis. Radiology. 2020 May;295(2):316-325. doi: 10.1148/radiol.2020191623. Epub 2020 Mar 10.

  PMID: 32154772 RESULT

• Sala S, Peretto G, Gramegna M, Palmisano A, Villatore A, Vignale D, De Cobelli F, Tresoldi M, Cappelletti AM, Basso C, Godino C, Esposito A. Acute myocarditis presenting as a reverse Tako-Tsubo syndrome in a patient with SARS-CoV-2 respiratory infection. Eur Heart J. 2020 May 14;41(19):1861-1862. doi: 10.1093/eurheartj/ehaa286. No abstract available.

  PMID: 32267502 RESULT

• Peretto G, Sala S, Lazzeroni D, Palmisano A, Gigli L, Esposito A, De Cobelli F, Camici PG, Mazzone P, Basso C, Della Bella P. Septal Late Gadolinium Enhancement and Arrhythmic Risk in Genetic and Acquired Non-Ischaemic Cardiomyopathies. Heart Lung Circ. 2020 Sep;29(9):1356-1365. doi: 10.1016/j.hlc.2019.08.018. Epub 2019 Nov 15.

  PMID: 32299760 RESULT

• Palmisano A, Vignale D, Peretto G, Busnardo E, Calcagno C, Campochiaro C, De Luca G, Sala S, Ferro P, Basso C, Del Maschio A, De Cobelli F, Esposito A. Hybrid FDG-PET/MR or FDG-PET/CT to Detect Disease Activity in Patients With Persisting Arrhythmias After Myocarditis. JACC Cardiovasc Imaging. 2021 Jan;14(1):288-292. doi: 10.1016/j.jcmg.2020.03.009. Epub 2020 Apr 15. No abstract available.

  PMID: 32305473 RESULT

• Peretto G, Casella M, Merlo M, Benedetti S, Rizzo S, Cappelletto C, Di Resta C, Compagnucci P, De Gaspari M, Dello Russo A, Casari G, Basso C, Sala S, Sinagra G, Della Bella P, Cooper LT Jr. Inflammation on Endomyocardial Biopsy Predicts Risk of MACE in Undefined Left Ventricular Arrhythmogenic Cardiomyopathy. JACC Clin Electrophysiol. 2023 Jul;9(7 Pt 1):951-961. doi: 10.1016/j.jacep.2022.10.032. Epub 2023 Jan 18.

  PMID: 36752457 RESULT

• Peretto G, Maranta F, Cianfanelli L, Sala S, Cianflone D. Outcomes of inflammatory cardiomyopathy following cardiac rehabilitation. J Cardiovasc Med (Hagerstown). 2023 Jan 1;24(1):59-61. doi: 10.2459/JCM.0000000000001388. No abstract available.

  PMID: 36574301 RESULT

• Palmisano A, Vignale D, Bruno E, Peretto G, De Luca G, Campochiaro C, Tomelleri A, Agricola E, Montorfano M, Esposito A. Cardiac magnetic resonance findings in acute and post-acute COVID-19 patients with suspected myocarditis. J Clin Ultrasound. 2023 May;51(4):613-621. doi: 10.1002/jcu.23416. Epub 2022 Dec 21.

  PMID: 36544331 RESULT

• Peretto G, Gulletta S, Slavich M, Campochiaro C, Vignale D, De Luca G, Palmisano A, Villatore A, Rizzo S, Cavalli G, De Gaspari M, Busnardo E, Gianolli L, Dagna L, Basso C, Esposito A, Sala S, Della Bella P, Mazzone P. Exercise Stress Test Late after Arrhythmic versus Nonarrhythmic Presentation of Myocarditis. J Pers Med. 2022 Oct 12;12(10):1702. doi: 10.3390/jpm12101702.

  PMID: 36294841 RESULT

• Peretto G, Busnardo E, Ferro P, Palmisano A, Vignale D, Esposito A, De Luca G, Campochiaro C, Sartorelli S, De Gaspari M, Rizzo S, Dagna L, Basso C, Gianolli L, Della Bella P, Sala S. Clinical Applications of FDG-PET Scan in Arrhythmic Myocarditis. JACC Cardiovasc Imaging. 2022 Oct;15(10):1771-1780. doi: 10.1016/j.jcmg.2022.02.029. Epub 2022 May 11.

  PMID: 36202457 RESULT

• Ammirati E, Raimondi F, Piriou N, Sardo Infirri L, Mohiddin SA, Mazzanti A, Shenoy C, Cavallari UA, Imazio M, Aquaro GD, Olivotto I, Pedrotti P, Sekhri N, Van de Heyning CM, Broeckx G, Peretto G, Guttmann O, Dellegrottaglie S, Scatteia A, Gentile P, Merlo M, Goldberg RI, Reyentovich A, Sciamanna C, Klaassen S, Poller W, Trankle CR, Abbate A, Keren A, Horowitz-Cederboim S, Cadrin-Tourigny J, Tadros R, Annoni GA, Bonoldi E, Toquet C, Marteau L, Probst V, Trochu JN, Kissopoulou A, Grosu A, Kukavica D, Trancuccio A, Gil C, Tini G, Pedrazzini M, Torchio M, Sinagra G, Gimeno JR, Bernasconi D, Valsecchi MG, Klingel K, Adler ED, Camici PG, Cooper LT Jr. Acute Myocarditis Associated With Desmosomal Gene Variants. JACC Heart Fail. 2022 Oct;10(10):714-727. doi: 10.1016/j.jchf.2022.06.013. Epub 2022 Sep 7.

  PMID: 36175056 RESULT

• Ramirez GA, Batani V, Moroni L, De Luca G, Pizzetti G, Sala S, Peretto G, Campochiaro C, Della-Torre E, Bozzolo EP, Dagna L. Cardiac Safety of mRNA-Based Vaccines in Patients with Systemic Lupus Erythematosus and Lupus-like Disorders with a History of Myocarditis. Pathogens. 2022 Sep 1;11(9):1001. doi: 10.3390/pathogens11091001.

  PMID: 36145434 RESULT

• Peretto G, Merlo M, Gentile P, Porcari A, Palmisano A, Vignale D, Sormani P, Rizzo S, De Gaspari M, Basso C, Bella PD, Sala S, Ammirati E, Sinagra G, Esposito A, Pedrotti P. Cardiac magnetic resonance abnormalities in patients with acute myocarditis proven by septal endomyocardial biopsy. Clin Res Cardiol. 2023 Mar;112(3):392-400. doi: 10.1007/s00392-022-02103-1. Epub 2022 Sep 16.

  PMID: 36112234 RESULT

• Nowatzke J, Guedeney P, Palaskas N, Lehmann L, Ederhy S, Zhu H, Cautela J, Francis S, Courand PY, Deswal A, Ewer SM, Aras M, Arangalage D, Ghafourian K, Fenioux C, Finke D, Peretto G, Zaha V, Itzhaki Ben Zadok O, Tajiri K, Akhter N, Levenson J, Baldassarre L, Power J, Huang S, Collet JP, Moslehi J, Salem JE; International ICI-myocarditis registry contributors. Coronary artery disease and revascularization associated with immune checkpoint blocker myocarditis: Report from an international registry. Eur J Cancer. 2022 Dec;177:197-205. doi: 10.1016/j.ejca.2022.07.018. Epub 2022 Aug 24.

  PMID: 36030143 RESULT

• Villatore A, Sala S, Stella S, Vignale D, Busnardo E, Esposito A, Basso C, Della Bella P, Mazzone P, Peretto G. Autoimmune Myocarditis and Arrhythmogenic Mitral Valve Prolapse: An Unexpected Overlap Syndrome. J Cardiovasc Dev Dis. 2021 Nov 6;8(11):151. doi: 10.3390/jcdd8110151.

  PMID: 34821704 RESULT

• Campochiaro C, Tomelleri A, Farina N, Cavalli G, De Luca G, Palmisano A, Peretto G, Esposito A, Rizzo S, Basso C, Matucci-Cerinic M, Dagna L. Myocarditis as a manifestation of Erdheim-Chester Disease: successful use of anti- IL1 and BRAF inhibitor combination therapy. Scand J Rheumatol. 2022 May;51(3):243-245. doi: 10.1080/03009742.2021.1992846. Epub 2021 Nov 17. No abstract available.

  PMID: 34788207 RESULT

• Peretto G, Mazzone P, Paglino G, Marzi A, Tsitsinakis G, Rizzo S, Basso C, Della Bella P, Sala S. Continuous Electrical Monitoring in Patients with Arrhythmic Myocarditis: Insights from a Referral Center. J Clin Med. 2021 Nov 1;10(21):5142. doi: 10.3390/jcm10215142.

  PMID: 34768662 RESULT

• Campochiaro C, Farina N, Tomelleri A, Ferrara R, Lazzari C, De Luca G, Bulotta A, Signorelli D, Palmisano A, Vignale D, Peretto G, Sala S, Esposito A, Garassino M, Gregorc V, Dagna L. Tocilizumab for the treatment of immune-related adverse events: a systematic literature review and a multicentre case series. Eur J Intern Med. 2021 Nov;93:87-94. doi: 10.1016/j.ejim.2021.07.016. Epub 2021 Aug 12.

  PMID: 34391591 RESULT

• Gentile P, Merlo M, Peretto G, Ammirati E, Sala S, Della Bella P, Aquaro GD, Imazio M, Potena L, Campodonico J, Foa A, Raafs A, Hazebroek M, Brambatti M, Cercek AC, Nucifora G, Shrivastava S, Huang F, Schmidt M, Muser D, Van de Heyning CM, Van Craenenbroeck E, Aoki T, Sugimura K, Shimokawa H, Cannata A, Artico J, Porcari A, Colopi M, Perkan A, Bussani R, Barbati G, Garascia A, Cipriani M, Agostoni P, Pereira N, Heymans S, Adler ED, Camici PG, Frigerio M, Sinagra G. Post-discharge arrhythmic risk stratification of patients with acute myocarditis and life-threatening ventricular tachyarrhythmias. Eur J Heart Fail. 2021 Dec;23(12):2045-2054. doi: 10.1002/ejhf.2288. Epub 2021 Jul 21.

  PMID: 34196079 RESULT

• Peretto G, Cappelletti AM, Spoladore R, Slavich M, Rizzo S, Palmisano A, Esposito A, De Cobelli F, Margonato A, Basso C, Della Bella P, Sala S. Right ventricular endomyocardial biopsy in patients with cardiac magnetic resonance showing left ventricular myocarditis. J Cardiovasc Med (Hagerstown). 2021 Jul 1;22(7):560-566. doi: 10.2459/JCM.0000000000001162.

  PMID: 34076604 RESULT

• Peretto G, Villatore A, Rizzo S, Esposito A, De Luca G, Palmisano A, Vignale D, Cappelletti AM, Tresoldi M, Campochiaro C, Sartorelli S, Ripa M, De Gaspari M, Busnardo E, Ferro P, Calabro MG, Fominskiy E, Monaco F, Cavalli G, Gianolli L, De Cobelli F, Margonato A, Dagna L, Scandroglio M, Camici PG, Mazzone P, Della Bella P, Basso C, Sala S. The Spectrum of COVID-19-Associated Myocarditis: A Patient-Tailored Multidisciplinary Approach. J Clin Med. 2021 May 4;10(9):1974. doi: 10.3390/jcm10091974.

  PMID: 34064463 RESULT

• Peretto G, Sala S, Camaschella C. Iron deficiency in chronic myocarditis: Assessment and prognostic significance. Eur J Intern Med. 2021 Jul;89:129-131. doi: 10.1016/j.ejim.2021.03.037. Epub 2021 Apr 21. No abstract available.

  PMID: 33893018 RESULT

• Peretto G, Barzaghi F, Cicalese MP, Di Resta C, Slavich M, Benedetti S, Giangiobbe S, Rizzo S, Palmisano A, Esposito A, De Cobelli F, Gulletta S, Basso C, Casari G, Aiuti A, Della Bella P, Sala S. Immunosuppressive therapy in childhood-onset arrhythmogenic inflammatory cardiomyopathy. Pacing Clin Electrophysiol. 2021 Mar;44(3):552-556. doi: 10.1111/pace.14153. Epub 2021 Jan 18.

  PMID: 33372694 RESULT

• Cenciarelli S, Calbi V, Barzaghi F, Bernardo ME, Oltolini C, Migliavacca M, Gallo V, Tucci F, Fraschetta F, Albertazzi E, Fratini ES, Consiglieri G, Giannelli S, Dionisio F, Sartirana C, Racca S, Camesasca C, Peretto G, Daverio R, Esposito A, De Cobelli F, Silvani P, Rabusin M, Cara A, Trabattoni D, Dispinseri S, Scarlatti G, Piemonti L, Lampasona V, Cicalese MP, Aiuti A, Ferrua F. Mild SARS-CoV-2 Infection After Gene Therapy in a Child With Wiskott-Aldrich Syndrome: A Case Report. Front Immunol. 2020 Nov 24;11:603428. doi: 10.3389/fimmu.2020.603428. eCollection 2020.

  PMID: 33329599 RESULT

• Peretto G, Sala S, De Luca G, Marcolongo R, Campochiaro C, Sartorelli S, Tresoldi M, Foppoli L, Palmisano A, Esposito A, De Cobelli F, Rizzo S, Thiene G, Basso C, Dagna L, Caforio ALP, Della Bella P. Immunosuppressive Therapy and Risk Stratification of Patients With Myocarditis Presenting With Ventricular Arrhythmias. JACC Clin Electrophysiol. 2020 Oct;6(10):1221-1234. doi: 10.1016/j.jacep.2020.05.013. Epub 2020 Jun 24.

  PMID: 33092747 RESULT

• Peretto G, Sala S, Basso C, Rizzo S, Radinovic A, Frontera A, Limite LR, Paglino G, Bisceglia C, De Luca G, Campochiaro C, Sartorelli S, Palmisano A, Esposito A, Busnardo E, Villatore A, Baratto F, Cireddu M, Marzi A, D'Angelo G, Gulletta S, Vergara P, De Cobelli F, Dagna L, Mazzone P, Della Bella P. Inflammation as a Predictor of Recurrent Ventricular Tachycardia After Ablation in Patients With Myocarditis. J Am Coll Cardiol. 2020 Oct 6;76(14):1644-1656. doi: 10.1016/j.jacc.2020.08.012.

  PMID: 33004129 RESULT

• Peretto G, De Luca G, Campochiaro C, Palmisano A, Busnardo E, Sartorelli S, Barzaghi F, Cicalese MP, Esposito A, Sala S. Telemedicine in myocarditis: Evolution of a mutidisciplinary "disease unit" at the time of COVID-19 pandemic. Am Heart J. 2020 Nov;229:121-126. doi: 10.1016/j.ahj.2020.07.015. Epub 2020 Aug 12.

  PMID: 32957030 RESULT

• Peretto G, Sala S, Della Bella P, Basso C, Cooper LT Jr. Reply: Genetic Basis for Acute Myocarditis Presenting With Ventricular Arrhythmias? J Am Coll Cardiol. 2020 Jul 7;76(1):126-128. doi: 10.1016/j.jacc.2020.05.014. No abstract available.

  PMID: 32616153 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Undefined a-priori. Will be considered in clinically-indicated.

MeSH Terms

Conditions

Myocarditis; Genetic Predisposition to Disease; Autoimmune Diseases; Arrhythmias, Cardiac; Cardiomyopathies

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Officials

• Paolo Della Bella, MD

  San Raffaele Scientific Institute, Milan, Italy

  STUDY CHAIR

Central Study Contacts

Giovanni Peretto, MD

CONTACT

+39 0226437482; peretto.giovanni@hsr.it

Simone Sala, MD

CONTACT

+39 0226437483; sala.simone@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: August 21, 2020
• Study Start: January 30, 2018
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2035
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

IT (1)