Status:
RECRUITING
Diagnostic Criteria in Cardiac Sarcoidosis
Lead Sponsor:
Heart Center Leipzig - University Hospital
Conditions:
Cardiac Sarcoidosis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of the study is to evaluate the accuracy of the current diagnostic criteria of cardiac sarcoidosis.
Detailed Description
Sarcoidosis is an inflammatory condition rarely affecting the heart, exhibiting fluctuating disease activity and eventually leading to ventricular fibrosis. Clinical presentation ranges from no sympto...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- unable or unwilling to provide informed consent
- patients who are pregnant or lactating
- noncompliant patients refusing the recommended therapy
- age \< 18 years
Key Trial Info
Start Date :
May 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04737317
Start Date
May 1 2023
End Date
January 1 2027
Last Update
May 9 2023
Active Locations (1)
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1
Heart Center of Leipzig
Leipzig, Germany, 04289