Canadian SCAD Study

Study Overview
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Brief Summary
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Natural history multicenter, prospective, observational registry with 10-year follow-up

Detailed Description
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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.

Official Title
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Canadian Spontaneous Coronary Artery Dissection (SCAD) Study and Genetic Sub-study (Prospective, Observational Registry With 10 Year Follow-up)

Conditions
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Spontaneous Coronary Artery Dissection, SCAD, Fibromuscular Dysplasia

Intervention / Treatment
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* Genetic: Genetic sub-study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted with ACS (STEMI, NSTEMI or unstable angina) Documented SCAD on a coronary angiogram (including diagnosis with OCT or IVUS) Exclusion Criteria: 1. Patients where SCAD is attributed to atherosclerotic coronary artery disease, with atherosclerotic coronary artery disease stenosis ≥50%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Single group observational study | Genetic: Genetic sub-study<br>* One time saliva sample collection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital CV outcomes | Composite (Death, MI, CVA, Unplanned revascularization, Heart failure) | From date of hospital admission to discharge up to 8 weeks | 
| Long-term CV outcomes | Composite (Death, MI, CVA, Revascularization, Heart failure) | at 10 Years post index event | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial healing post SCAD | Angiographic healing | at 6 weeks post discharge post index event | 
| Coronary revascularization success | Composite (TIMI 3 flow, <50% stenosis, and no residual dissection) | During index hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromuscular displasia (FMD), Myocardial Infarction, Myocardial Infarction in women, Non-atherosclerotic coronary artery disease (NACAD), Myocardial Infarction with no obstructive coronary artery disease (MINOCA), SCAD, Spontaneous Coronary Artery Dissection