Evaluating diagnostic criteria for cardiac sarcoidosis
Evaluation of Diagnostic Criteria in Cardiac Sarcoidosis - an Observational Study
This study is testing how well current methods for diagnosing cardiac sarcoidosis work to help find patients who might need treatment sooner.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Heart Center Leipzig - University Hospital Academic / other |
| Locations | 1 site (Leipzig) |
| Trial ID | NCT04737317 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the accuracy of current diagnostic criteria for cardiac sarcoidosis, a rare inflammatory condition affecting the heart. Patients suspected of having cardiac sarcoidosis will undergo a comprehensive diagnostic work-up, including clinical evaluations, ECG, laboratory tests, imaging studies like PET and CMR, and endomyocardial biopsy. The study seeks to identify discrepancies among existing diagnostic tools and improve early identification of patients who may benefit from immunosuppressive therapy.
Who should consider this trial
Good fit: Ideal candidates include patients under 65 years with suspected cardiac sarcoidosis based on specific clinical presentations.
Not a fit: Patients with confirmed coronary artery disease or those over 65 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and earlier treatment for patients with cardiac sarcoidosis.
How similar studies have performed: While there have been studies on cardiac sarcoidosis, this specific evaluation of diagnostic criteria is novel and addresses significant discrepancies in current practices.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Leipzig
- Heart Center of Leipzig — Leipzig, Germany (Recruiting)
Study contacts
- Principal investigator: Borislav Dinov, MD — Heart Center Leipzig - University Hospital, Department Electrophysiology
- Study coordinator: Borislav Dinov, MD
- Email: borislav.dinov@helios-gesundheit.de
- Phone: +49 341 865 1431
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.