Inflammatory Cardiomyopathy Bern Registry

NCT04774549 | Active Not Recruiting

• 1 other identifier: 2020-01100
• Study Type: observational
• Target: 1,125
• Locations: 1 country
• Sites: 1

Brief Summary

Inflammatory cardiomyopathies are associated with inflammation and impaired function of the heart muscle and encompass myo- and pericarditis and cardiac sarcoidosis. Due to the heterogeneity of the clinical manifestations, establishing the diagnosis and prediction of outcome is challenging. Specifically for myocarditis, it is associated with acute and chronic heart failure and sudden cardiac death. Cardiac magnetic resonance imaging (CMR) allows imaging of tissue characteristics (i.e. edema and fibrosis). CMR is the primary diagnostic tool in myocarditis and can also be used for differentiating other inflammatory diseases. Beside the presence of edema, also hyperemia/capillary leak, fibrosis and myocardial function can be assessed and quantified. Previous studies demonstrated the prognostic role of CMR features beyond traditional markers of LV function, but are limited to smaller cohorts and single-center studies. Furthermore, CMR is a rapidly developing modality and as new features of the modality become available, additional research is needed to identify which combination of parameters optimize risk stratification of this heterogenous inflammatory cardiomyopathy. Hence, the goal of the registry is to investigate the diagnostic and prognostic role of clinical techniques in inflammatory cardiomyopathies, particularly CMR, and which combination of features provide the highest potential. This analysis will include new advanced CMR techniques but will also assess the role of other techniques that may be more cost-efficient and more widely available, which could be used as a precursor to CMR imaging exams.

Conditions

Myocarditis; Cardiac Sarcoidosis; Pericarditis

Keywords

Myocarditis; Cardiac sarcoidosis; Pericarditis; CMR feature tracking; Strain; T1 and T2 Mapping; LGE; Outcomes; MACE

Outcome Measures

Primary Outcomes (3)

• LV (left ventricle) and RV (right ventricle) function as assessed by CMR feature tracking as predictor for MACE (major adverse cardiac Event)

  Global and regional longitudinal (%), circumferential (%) and radial (%) strain measurements are used to quantify LV and RV function. MACE is defined as a composite of sustained ventricular tachycardia, recurrent myocarditis, hospitalization for heart failure and all-cause death all-cause death.

  5 years

• LV and RV tissue characterization as assessed by T1 and T2 mapping as predictor for MACE

  Global and regional tissue characteristics are assessed by repetitive T1 and T2 mapping (global and regional T1 and T2 time (ms)). MACE is defined as a composite of major cardiovascular endpoints listed above.

  5 years

• Presence of myocardial fibrosis and scar as predictor for MACE

  Global and regional myocardial tissue is characterized by gadolinium contrast agent application. The presence and extent (% and total mass (g)) of late gadolinium enhancement is evaluated as a predictor for MACE.

  5 years

Secondary Outcomes (2)

• Prognostic impact of sports cessation in acute myocarditis

  Repetitive questionnaire at baseline, after 6 and 12 months as well as after 5 years

• Prognostic impact of fragmented QRS in acute myocarditis

  5 years

Study Arms (1)

Patients with inflammatory cardiomyopathy

Patients referred to CMR for suspected/known inflammatory cardiomyopathy and/or diagnosed inflammatory cardiomyopathy from CMR findings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to CMR for suspected/known inflammatory cardiomyopathy and/or diagnosed inflammatory cardiomyopathy from CMR findings

You may qualify if:

• Referral to CMR for suspected/known inflammatory cardiomyopathy and/or diagnosed inflammatory cardiomyopathy from CMR findings
• Ability to provide informed consent (knowledge of project languages),
• Age \>18 years
• Inability to give consent or existence of a written or documented oral refusal.
• Evidence of coronary artery disease (CAD) by either previous documented medical history, any imaging findings of CAD, or significant epicardial coronary stenosis by invasive coronary angiography;
• Evidence of hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, cardiac amyloidosis, Takotsubo cardiomyopathy, Loeffler endocarditis, ventricular noncompaction, cardiac tumor, pulmonary embolism, or persistent severe valve disease.
• Recent cardiovascular surgery or intervention (\<90 days prior to CMR)
• Heart transplant

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Cardiology, University Hospital Bern, Inselspital, Bern

Bern, 3010, Switzerland

Location

Related Publications (5)

• Grani C, Eichhorn C, Biere L, Murthy VL, Agarwal V, Kaneko K, Cuddy S, Aghayev A, Steigner M, Blankstein R, Jerosch-Herold M, Kwong RY. Prognostic Value of Cardiac Magnetic Resonance Tissue Characterization in Risk Stratifying Patients With Suspected Myocarditis. J Am Coll Cardiol. 2017 Oct 17;70(16):1964-1976. doi: 10.1016/j.jacc.2017.08.050.

  PMID: 29025553 BACKGROUND

• Fischer K, Obrist SJ, Erne SA, Stark AW, Marggraf M, Kaneko K, Guensch DP, Huber AT, Greulich S, Aghayev A, Steigner M, Blankstein R, Kwong RY, Grani C. Feature Tracking Myocardial Strain Incrementally Improves Prognostication in Myocarditis Beyond Traditional CMR Imaging Features. JACC Cardiovasc Imaging. 2020 Sep;13(9):1891-1901. doi: 10.1016/j.jcmg.2020.04.025. Epub 2020 Jul 15.

  PMID: 32682718 BACKGROUND

• Fischer K, Marggraf M, Stark AW, Kaneko K, Aghayev A, Guensch DP, Huber AT, Steigner M, Blankstein R, Reichlin T, Windecker S, Kwong RY, Grani C. Association of ECG parameters with late gadolinium enhancement and outcome in patients with clinical suspicion of acute or subacute myocarditis referred for CMR imaging. PLoS One. 2020 Jan 10;15(1):e0227134. doi: 10.1371/journal.pone.0227134. eCollection 2020.

  PMID: 31923225 BACKGROUND

• Bernhard B, Tanner G, Garachemani D, Schnyder A, Fischer K, Huber AT, Safarkhanlo Y, Stark AW, Guensch DP, Schutze J, Greulich S, Bastiaansen JAM, Pavlicek-Bahlo M, Benz DC, Kwong RY, Grani C. Predictive value of cardiac magnetic resonance right ventricular longitudinal strain in patients with suspected myocarditis. J Cardiovasc Magn Reson. 2023 Aug 17;25(1):49. doi: 10.1186/s12968-023-00957-6.

  PMID: 37587516 DERIVED

• Bernhard B, Schnyder A, Garachemani D, Fischer K, Tanner G, Safarkhanlo Y, Stark AW, Schutze J, Pavlicek-Bahlo M, Greulich S, Johner C, Wahl A, Benz DC, Kwong RY, Grani C. Prognostic Value of Right Ventricular Function in Patients With Suspected Myocarditis Undergoing Cardiac Magnetic Resonance. JACC Cardiovasc Imaging. 2023 Jan;16(1):28-41. doi: 10.1016/j.jcmg.2022.08.011. Epub 2022 Oct 19.

  PMID: 36599567 DERIVED

MeSH Terms

Conditions

Myocarditis; Pericarditis; Sprains and Strains

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Wounds and Injuries

Study Officials

• Christoph Gräni, MD, PhD

  Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: March 1, 2021
• Study Start: January 1, 2005
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 5, 2024

Record last verified: 2024-11

Locations

CH (1)