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RECRUITINGOBSERVATIONAL

Cardiac Sarcoidosis Multi-Center Prospective Cohort

Cardiac Sarcoidosis Multi-Center Prospective Cohort Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 this project. Recent physician surveys regarding CS, in Canada and the US, found that current clinical practice varies widely. The 2008 American College of Cardiology/American Heart Association/Heart Rhythm society guidelines recommend implantation of a defibrillator (Class IIa recommendation) to prevent sudden cardiac death. The most recent Canadian device therapy guidelines do not mention CS. A multi-center collaborative approach to study CS is greatly needed." The investigators propose exactly that i.e. a multi-center prospective cohort to start to answer clinical questions. The investigators have formed the CANADIAN CARDIAC SARCOIDOSIS RESEARCH GROUP. The group includes respirologists with an interest in sarcoidosis, cardiac electrophysiologists, cardiac imaging specialists with extensive experience in imaging of sarcoidosis and biostatisticians. The research will be in two phases; a registry of current diagnostic approaches, treatment and prognosis, and a randomized clinical trial of the effect of corticosteroid treatment on the clinical course of cardiac sarcoidosis.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: - unable or unwilling to provide willing to sign a consent form - patients who are pregnant or lactating - patients with known claustrophobia - age \< 18 years Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Locations (14)

Libin Cardiovascular Institute of Alberta
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
QEII Health Sciences Center
Halifax, Nova Scotia, Canada
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Centre Hospitalier de l"Universite de Montreal-Hotel Dieu
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Prairie Vascular Research Inc-Regina General Hospital
Regina, Saskatchewan, Canada
Hokkaido University
Sapporo, Japan