Diagnostic Criteria in Cardiac Sarcoidosis

NCT04737317 | Recruiting

• 1 other identifier: 20201231PV1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the accuracy of the current diagnostic criteria of cardiac sarcoidosis.

Conditions

Cardiac Sarcoidosis

Outcome Measures

Primary Outcomes (2)

• Clinical recovery with immunosuppressive therapy

  Number of patients showing clinical recovery defined as improvement of at least one of the following: decrease of the heart failure class, decrease of fatigue assessed by FAS score, increase of KSQ score with at least 10 points, reduction of burden of ventricular arrhythmias assessed with Holter ECG or device interrogations, improvement of the AV block

  1 year

• Imaging recovery with immunosuppressive therapy

  Number of patients with improvement of the cardiac imaging defined as one of the following: increase of the EF with at least 10%, decrease of the PET activity, decrease of the scar or edema in CMR

  1 year

Secondary Outcomes (9)

• Cardiac mortality

  2 years

• All-cause mortality

  2 years

• Unplanned hospitalizations

  2 years

• Change in LV-EF from baseline

  2 years

• Change in RV function

  2 years

Interventions

ECG, Echo, laboratory tests, CMR, PET-CT, Biopsy DIAGNOSTIC_TEST

ECG - 12 leads ECG Echo: transthoracic echocardiography laboratory tests: full blood count, electrolytes, creatinine, high sensitive cardiac troponin T, angiontesin converting enzyme, soluble interleukin-2 receptor, cardiac magnetic resonance imaging: 1.5 Tesla scanner, Conventional cine imaging and late gadolinium enhancement imaging PET-CT: 18F-fluorodeoxyglucose (FDG)- positron emission tomograph Biopsy: cardiac biopsy = endomyocardial biopsy, left and right ventricle, at least 5 specimens in formaldehyd and 3 specimens for testing of infectious agents Biopsy: extracardiac biopsy, as accessible according to imaging

Eligibility Criteria

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

Study Population

Patients presenting at the Heart Center Leipzig, elective and urgent admissions

You may qualify if:

• patients with suspected CS due to the following presentations:
• age \< 65 years and new higher degree AV block, causative coronary artery disease excluded
• age \< 65 years and new ventricular tachycardia, causative coronary artery disease excluded
• age \< 65 years and ventricular tachycardia, causative coronary artery disease excluded
• extracardiac sarcoidosis and cardiac involvement suggested (palpitations, abnormal ECG, abnormal echocardiography)
• To diagnose CS one of the following diagnostic tools will be used:
• A) World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG)
• B) Heart Rhythm Society expert consensus statement on the diagnosis and management of arrhythmias associated with cardiac sarcoidosis
• C) Japanese Society of Nuclear Cardiology (JSNC)
• Patients whit histological confirmation from myocardial tissue fullfil will be defined as proven CS. (Group 1)
• Patients with clinical and imaging findings highly suggesting CS, but without histological confirmation from myocardial biopsy will be defined as probable CS (Group 2)
• Patients who do not fullfil the criteria or exhibiting findings suggesting an alternative, more likely diagnosis, will be considered as unlikely CS (Group 3)

You may not qualify if:

• unable or unwilling to provide informed consent
• patients who are pregnant or lactating
• noncompliant patients refusing the recommended therapy
• age \< 18 years

Sponsors & Collaborators

• Heart Center Leipzig - University Hospital: lead

Study Sites (1)

Heart Center of Leipzig

Leipzig, 04289, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, myocardial biopsy specimens

MeSH Terms

Interventions

Electrocardiography; Caves; Positron Emission Tomography Computed Tomography; Biopsy

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Geological Phenomena; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Borislav Dinov, MD

  Heart Center Leipzig - University Hospital, Department Electrophysiology

  PRINCIPAL INVESTIGATOR

• Laura Ueberham, MD

  Heart Center Leipzig - University Hospital, Department Electrophysiology

  STUDY CHAIR

Central Study Contacts

Borislav Dinov, MD

CONTACT

+49 341 865 1431; borislav.dinov@helios-gesundheit.de

Laura Ueberham, MD

CONTACT

+49341 865 1431; laura.ueberham@helios-gesundheit.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ventricular Tachycardia Unit

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 3, 2021
• Study Start: May 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

DE (1)