RecruitingNCT04737317

Diagnostic Criteria in Cardiac Sarcoidosis

Evaluation of Diagnostic Criteria in Cardiac Sarcoidosis - an Observational Study


Sponsor

Heart Center Leipzig - University Hospital

Enrollment

100 participants

Start Date

May 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria12

  • 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 Criteria4

  • unable or unwilling to provide informed consent
  • patients who are pregnant or lactating
  • noncompliant patients refusing the recommended therapy
  • age < 18 years

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Interventions

DIAGNOSTIC_TESTECG, 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

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NCT04737317


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