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Cardiac Sarcoidosis Multi-Center Prospective Cohort

Recruitingn/aAges 18 Years - 99 YearsAllOttawa Heart Institute Research Corporation
NCT01477359 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Recent data has shown that sarcoidosis, presenting initially with cardiac manifestations (CS) of either conduction system disease or cardiomyopathy and sustained VT, is not uncommon. A Canadian physician survey found that most physicians do not investigate for CS as a possibility in these situations. Thus many patients with clinically important CS are going un-diagnosed. A study from Finland showed that missing the diagnosis of CS in these patients' leads to significant mortality and morbidity. There are no published clinical consensus guidelines on treatment of CS. Corticosteroid therapy is advocated by most experts. This is based on very modest data from small retrospective observational studies using variable definitions of clinical response. The effect of corticosteroid treatment on the clinical course of CS has not been studied in prospective studies and will be one of the aims of

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📋 Eligibility rules (as published)
Inclusion Criteria: To diagnose Clinically Manifest CS all following criteria must be met: (i) Positive biopsy\* for Sarcoid (either EMB or extra-cardiac) AND/OR (ii) CT Chest highly suggestive of pulmonary sarcoidosis AND (iii) one or more of the following clinical features: * advanced conduction system disease (sustained Mobitz II AV block or third degree AV block) * non- sustained or sustained ventricular arrhythmia * ventricular dysfunction (LVEF \< 50% and/or RVEF \< 40%) AND (iv) No alternative explanation for clinical features AND (v) FDG-PET suggestive of active CS To diagnose clinically silent CS all of the following criteria must be met (i) Biopsy proven extra-cardiac sarcoidosis AND/OR (ii) CT Chest highly suggestive of pulmonary sarcoidosis AND (iii) CMR suggestive of cardiac sarcoidosis AND (iv) Does not have criteria for clinically manifest CS ie. should not have any of following * advanced conduction system disease (sustained Mobitz II AV block or third degree AV block) * non- sustained or sustained ventricular arrhythmia * ventricular dysfunction (LVEF \< 50% and/or RVEF \< 40%) Patients with negative CMR will be designated as 'extra-cardiac sarcoidosis with no evidence of CS' and followed as control Exclusion Criteria: * unable or unwilling to provide informed consent * patients who are pregnant or lactating * patients with known claustrophobia * age \< 18 years
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What it tests

  • Not listed
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Where

14 sites
Libin Cardiovascular Institute of Alberta
Calgary, Canada
University of Alberta Hospital
Edmonton, Canada
St. Paul's Hospital
Vancouver, Canada
QEII Health Sciences Center
Halifax, Canada
Hamilton Health Sciences Centre
Hamilton, Canada
London Health Sciences Centre
London, Canada
Southlake Regional Health Centre
Newmarket, Canada
University of Ottawa Heart Institute
Ottawa, Canada

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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