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RECRUITINGOBSERVATIONAL

Diagnostic Criteria in Cardiac Sarcoidosis

Evaluation of Diagnostic Criteria in Cardiac Sarcoidosis - an Observational Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - patients with suspected CS due to the following presentations: 1. age \< 65 years and new higher degree AV block, causative coronary artery disease excluded 2. age \< 65 years and new ventricular tachycardia, causative coronary artery disease excluded 3. age \< 65 years and ventricular tachycardia, causative coronary artery disease excluded 4. 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) Who Should NOT Join This Trial: - unable or unwilling to provide willing to sign a consent form - patients who are pregnant or lactating - noncompliant patients refusing the recommended therapy - age \< 18 years Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * patients with suspected CS due to the following presentations: 1. age \< 65 years and new higher degree AV block, causative coronary artery disease excluded 2. age \< 65 years and new ventricular tachycardia, causative coronary artery disease excluded 3. age \< 65 years and ventricular tachycardia, causative coronary artery disease excluded 4. 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) Exclusion Criteria: * unable or unwilling to provide informed consent * patients who are pregnant or lactating * noncompliant patients refusing the recommended therapy * age \< 18 years

Treatments Being Tested

DIAGNOSTIC_TEST

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

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

Locations (1)

Heart Center of Leipzig
Leipzig, Germany