Status:
RECRUITING
Cardiac Sarcoidosis Multi-Center Prospective Cohort
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Collaborating Sponsors:
Ontario Ministry of Health and Long Term Care
Canadian Institutes of Health Research (CIHR)
Conditions:
Cardiac Sarcoidosis
Eligibility:
All Genders
18-99 years
Brief Summary
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 physic...
Detailed Description
Baseline assessment of Clinically Manifest CS patients consists of: history, echocardiogram, ECG, chest CT scan, FDG-PET scan, blood for biomarkers within 2 months of the PET scan, cardiac MRI and pos...
Eligibility Criteria
Inclusion
- 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
- unable or unwilling to provide informed consent
- patients who are pregnant or lactating
- patients with known claustrophobia
- age \< 18 years
Key Trial Info
Start Date :
August 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT01477359
Start Date
August 1 2012
End Date
December 1 2025
Last Update
May 8 2024
Active Locations (14)
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1
Libin Cardiovascular Institute of Alberta
Calgary, Alberta, Canada, T2N 2T9
2
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
3
St. Paul's Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
4
QEII Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 3A7