Cardiac Sarcoidosis Multi-Center Prospective Cohort
Cardiac SarcoidosisRecent 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.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
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
Study Location
St. Paul's Hospital
St. Paul's HospitalVancouver, British Columbia
Canada
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Shanta Chakrabarti, MD
Southlake Regional Health Centre
Southlake Regional Health CentreNewmarket, Ontario
Canada
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Bernice Tsang, MD
Centre Hospitalier de l"Universite de Montreal-Hotel Dieu
Centre Hospitalier de l"Universite de Montreal-Hotel DieuMontreal, Quebec
Canada
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Julie Fleury, RN
University of Alberta Hospital
University of Alberta HospitalEdmonton, Alberta
Canada
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Tomascz Hruczkowski, MD
London Health Sciences Centre
London Health Sciences CentreLondon, Ontario
Canada
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Lorne Gula, MD
Montreal Heart Institute
Montreal Heart InstituteMontreal, Quebec
Canada
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Lena Rivard, MD
QEII Health Sciences Center
QEII Health Sciences CenterHalifax, Nova Scotia
Canada
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Kim Anderson, MD
McGill University Health Centre
McGill University Health CentreMontreal, Quebec
Canada
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Fiorella Rafti
University of Ottawa Heart Institute
University of Ottawa Heart InstituteOttawa, Ontario
Canada
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Libin Cardiovascular Institute of Alberta
Libin Cardiovascular Institute of AlbertaCalgary, Alberta
Canada
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Russell Quinn, MD
Hamilton Health Sciences Centre
Hamilton Health Sciences CentreHamilton, Ontario
Canada
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Jeff Healey, MD
Gerard Cox, MD
Toronto General Hospital
Toronto General HospitalToronto, Ontario
Canada
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Andrew Ha, MD
Prairie Vascular Research Inc-Regina General Hospital
Prairie Vascular Research Inc-Regina General HospitalRegina, Saskatchewan
Canada
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- Study Sponsored By
- Ottawa Heart Institute Research Corporation
- Participants Required
- More Information
- Study ID:
NCT01477359