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
Study summary
The purpose of the study is to evaluate the accuracy of the current diagnostic criteria of cardiac sarcoidosis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Clinical recovery with immunosuppressive therapy — 1 year 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
Imaging recovery with immunosuppressive therapy — 1 year 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
Trial sites (1)
Facility
City
Region
Status
Heart Center of Leipzig
Leipzig
Germany
Recruiting
More Heart Center Leipzig - University Hospital trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.