Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1500 participants
OBSERVATIONAL
2012-08-31
2025-12-31
Brief Summary
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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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Detailed Description
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Follow-up and clinical management of clinically manifest patients diagnosed with CS will occur at 3-6 months with a repeat FDG-PET scan and blood biomarkers. Follow-up will then be annually with an echo and ECG. Treatment with steroids/immunosuppressants and device therapy will be at the discretion of the treating physician.
Baseline assessment of patients diagnosed with extra-cardiac sarcoidosis and being screened for CS consists of: history, echocardiogram, ECG, holter, chest CT scan, biopsy, and cardiac MRI (CMR). If the CMR is suggestive of CS the patient will be have a FDG-PET scan done and be followed as a Clinically Silent patient. They will be contacted every 2 years. If the CMR is negative the patient will be followed as a extra-cardiac sarcoidosis patient with no evidence of CS and be in the control group. They will be contacted at 5 years and at the time of study completion.
All patients will be followed until the last patient recruited has been followed for 4 years.
The occurrence of the primary and secondary outcomes will be assessed in treated and untreated patients.
There will be 2 imaging core labs. The PET core lab will be located at UOHI under the direction of Dr. Robert Beanlands. The CMR core lab will be under the direction of Dr. Mathias Friedrich (McGill University). All scans will be read in the core labs by physicians who are blinded to the clinical details of the patients.
The Biomarker core lab will be at The University of Ottawa Heart Institute under the leadership of Dr P Liu.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CS screened as underlying etiology
1. Patients with active Clinically Manifest CS
2. Patients diagnosed with extra-cardiac sarcoidosis and being screened for CS
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
(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
* patients who are pregnant or lactating
* patients with known claustrophobia
* age \< 18 years
18 Years
99 Years
ALL
No
Sponsors
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Ontario Ministry of Health and Long Term Care
OTHER_GOV
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Ottawa Heart Institute Research Corporation
OTHER
Responsible Party
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Principal Investigators
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David Birnie, MD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Heart Institute Research Corporation
Pablo Nery, MD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Heart Institute Research Corporation
Rob Beanlands, MD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Heart Institute Research Corporation
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Russell Quinn, MD
Role: primary
Tomascz Hruczkowski, MD
Role: primary
Shanta Chakrabarti, MD
Role: primary
Kim Anderson, MD
Role: primary
Jeff Healey, MD
Role: primary
Gerard Cox, MD
Role: backup
Lorne Gula, MD
Role: primary
Bernice Tsang, MD
Role: primary
Andrew Ha, MD
Role: primary
Lena Rivard, MD
Role: primary
Julie Fleury, RN
Role: primary
Fiorella Rafti
Role: primary
References
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Weng W, Wiefels C, Chakrabarti S, Nery PB, Celiker-Guler E, Healey JS, Hruczkowski TW, Quinn FR, Promislow S, Medor MC, Spence S, Odabashian R, Alqarawi W, Juneau D, de Kemp R, Leung E, Beanlands R, Birnie D. Atrial Arrhythmias in Clinically Manifest Cardiac Sarcoidosis: Incidence, Burden, Predictors, and Outcomes. J Am Heart Assoc. 2020 Sep;9(17):e017086. doi: 10.1161/JAHA.120.017086. Epub 2020 Aug 20.
Martineau P, Pelletier-Galarneau M, Juneau D, Leung E, Nery PB, de Kemp R, Beanlands R, Birnie D. Imaging Cardiac Sarcoidosis With FLT-PET Compared With FDG/Perfusion-PET: A Prospective Pilot Study. JACC Cardiovasc Imaging. 2019 Nov;12(11 Pt 1):2280-2281. doi: 10.1016/j.jcmg.2019.06.020. Epub 2019 Aug 14. No abstract available.
Other Identifiers
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UOHI-04
Identifier Type: -
Identifier Source: org_study_id
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