An observational study in Spontaneous Coronary Artery Dissection, SCAD and Fibromuscular Dysplasia, sponsored by Cardiology Research UBC. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-28.
Sponsored by Cardiology Research UBC · Observational
Natural history multicenter, prospective, observational registry with 10-year follow-up
Spontaneous coronary artery dissection (SCAD) is an under-diagnosed and poorly understood condition that frequently affects young women without conventional cardiovascular (CV) risk factors and can result in myocardial infarction (MI), cardiac arrest, and death. This condition has not been adequately studied, and there are no randomized controlled trials to guide treatment. Furthermore, SCAD has been frequently misdiagnosed due to the current "gold-standard" coronary angiography limitations. As such, there are uncertainties with the diagnosis and management of SCAD patients. Therefore, the investigators propose a large prospective multicenter Canadian SCAD Study to ascertain the natural history of predisposing arteriopathies and treatment strategy on short and long-term CV outcomes to design future randomized controlled trials.
This is a multicenter, prospective, international, observational natural history study with a planned total enrolment of 3,000 patients with SCAD. The investigators plan to recruit patients from major cardiac catheterization centers across Canada and several centers in the United States and internationally. The research team successfully enrolled 750 patients prospectively in the "Canadian SCAD Cohort Study" from 22 sites in North America. This current study will be an extension of that study, now named the "Canadian SCAD Study." It will continue enrolment for a total of 3,000 patients internationally (from >35 sites). Detailed baseline demographics, targeted history for precipitating stressors and predisposing conditions, and investigations for predisposing conditions will be performed during the study. Patients will be prospectively followed long-term for up to 10 years for CV events. The study is approved, allowing potential participants to be enrolled using an electronic consent form irrespective of their geographic location and directly communicating with the study team at UBC.
386 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 183 across 180 observational studies indexed under Aortic Dissection.
Browse Aortic Dissection studies →Cardiology Research UBC is the lead sponsor of 18 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients admitted with ACS (STEMI, NSTEMI or unstable angina) and diagnosed with SCAD during direct coronary angiography. The study imaging corelab will review all films before participant enrollment.
Exclusion Criteria:
Single group observational study
Genetic: Genetic sub-study
One time saliva sample collection
In-hospital CV outcomes
Composite (Death, MI, CVA, Unplanned revascularization, Heart failure)
Time frame: From date of hospital admission to discharge up to 8 weeks
Long-term CV outcomes
Composite (Death, MI, CVA, Revascularization, Heart failure)
Time frame: at 10 Years post index event
Arterial healing post SCAD
Angiographic healing
Time frame: at 6 weeks post discharge post index event
Coronary revascularization success
Composite (TIMI 3 flow, \<50% stenosis, and no residual dissection)
Time frame: During index hospitalization
Plan to share: No
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Cardiology Research UBC