Actively Recruiting
Cardiac Sarcoidosis Multi-Center Prospective Cohort
Led by Ottawa Heart Institute Research Corporation · Updated on 2024-05-08
1500
Participants Needed
14
Research Sites
695 weeks
Total Duration
On this page
Sponsors
O
Ottawa Heart Institute Research Corporation
Lead Sponsor
O
Ontario Ministry of Health and Long Term Care
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cardiac Sarcoidosis Multi-Center Prospective Cohort
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Positive biopsy for sarcoid (either endomyocardial or extra-cardiac) and/or chest CT highly suggestive of pulmonary sarcoidosis
- One or more clinical features: advanced conduction system disease, ventricular arrhythmia, or ventricular dysfunction (LVEF < 50% and/or RVEF < 40%)
- No alternative explanation for clinical features
- FDG-PET scan suggestive of active cardiac sarcoidosis
- Biopsy proven extra-cardiac sarcoidosis and/or chest CT highly suggestive of pulmonary sarcoidosis
- Cardiac MRI suggestive of cardiac sarcoidosis
- For clinically silent CS, absence of advanced conduction disease, ventricular arrhythmia, or ventricular dysfunction
- Adults aged 18 years and older
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Pregnant or lactating individuals
- Known claustrophobia
- Age under 18 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Libin Cardiovascular Institute of Alberta
Calgary, Alberta, Canada, T2N 2T9
Actively Recruiting
2
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
3
St. Paul's Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
4
QEII Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 3A7
Actively Recruiting
5
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
6
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Actively Recruiting
7
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
Actively Recruiting
8
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Actively Recruiting
9
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
10
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Actively Recruiting
11
Centre Hospitalier de l"Universite de Montreal-Hotel Dieu
Montreal, Quebec, Canada, H2W 1T8
Not Yet Recruiting
12
McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
Actively Recruiting
13
Prairie Vascular Research Inc-Regina General Hospital
Regina, Saskatchewan, Canada, S4P 0W5
Actively Recruiting
14
Hokkaido University
Sapporo, Japan, 060-8638
Actively Recruiting
Research Team
J
Janine E Ryan, BA(H), CCRP
CONTACT
D
David Birnie, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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