Actively Recruiting
Evaluation of Diagnostic Criteria in Cardiac Sarcoidosis Using Clinical, Imaging, and Biopsy Methods - an Observational Study
Led by Heart Center Leipzig - University Hospital · Updated on 2023-05-09
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy of current diagnostic criteria for cardiac sarcoidosis, a rare inflammatory condition that affects the heart and can lead to serious complications like arrhythmias and heart failure. The study aims to understand how well clinical, ECG, laboratory, imaging, and biopsy criteria predict disease activity and patient outcomes. Participants suspected of having cardiac sarcoidosis will undergo a thorough diagnostic work-up including symptom evaluation, family history, ECG, chest X-ray, blood tests, PET scans, cardiac MRI, and heart biopsies. Based on guideline recommendations, patients will be classified into three groups: proven cardiac sarcoidosis, probable cardiac sarcoidosis, and unlikely cardiac sarcoidosis. Those with proven or probable disease will receive immunosuppressive treatment mainly with glucocorticoids, and their progress will be monitored at 3, 6, 12, and 24 months. During follow-up, researchers will assess symptoms, fatigue, heart rhythm monitoring, lab results, and imaging findings using questionnaires and tests like Holter-ECG and PET/CMR scans. The study will compare clinical and imaging improvements between groups and evaluate the predictive value of diagnostic criteria. This will help develop a diagnostic and predictive score to guide future patient care and therapy decisions.
CONDITIONS
Brief Title
Diagnostic Criteria in Cardiac Sarcoidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with suspected cardiac sarcoidosis presenting with one of the following: age under 65 years and new high-degree AV block with coronary artery disease excluded
- Age under 65 years with new ventricular tachycardia and coronary artery disease excluded
- Age under 65 years with ventricular tachycardia and coronary artery disease excluded
- Patients with extracardiac sarcoidosis and signs of cardiac involvement such as palpitations, abnormal ECG, or abnormal echocardiography
- Diagnosis based on established criteria from WASOG, Heart Rhythm Society, or Japanese Society of Nuclear Cardiology
- Patients classified as proven or probable cardiac sarcoidosis based on clinical, imaging, and biopsy findings
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Pregnant or breastfeeding women
- Patients refusing recommended therapy or noncompliant
- Individuals younger than 18 years old
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants undergo detailed diagnostic testing including ECG, echocardiography, laboratory tests, cardiac magnetic resonance imaging (CMR), positron emission tomography (PET), and cardiac and extracardiac biopsies to assess for cardiac sarcoidosis.
1 to 3 visits depending on tests required
Duration - Up to 24 months
Participants classified with proven or probable cardiac sarcoidosis receive immunosuppressive therapy and are monitored for clinical and imaging recovery with follow-up assessments. Participants with unlikely cardiac sarcoidosis serve as a reference group and are observed.
Visits at 3, 6, 12, and 24 months including symptom evaluation, Holter-ECG, pacemaker interrogation, laboratory tests, and imaging with PET and CMR
Trial Site Locations
Total: 1 location
1
Heart Center of Leipzig
Leipzig, Germany, 04289
Actively Recruiting
Research Team
B
Borislav Dinov, MD
L
Laura Ueberham, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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