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| Name | Class |
|---|---|
| John GB Mancini, MD | UNKNOWN |
| Karin Humphries, DSc | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Single group observational study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genetic sub-study | Genetic | One time saliva sample collection |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
1. Patients where SCAD is attributed to atherosclerotic coronary artery disease, with atherosclerotic coronary artery disease stenosis ≥50%
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew Starovoytov, MD | Contact | 6048755079 | a.starovoytov@ubc.ca | |
| Johandra Argote Parolis, MD | Contact | 6048754111 | 63344 | j.argoteparolis@ubc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Saw, MD | Cardiology Research UBC / Vancouver General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital | Recruiting | Vancouver | British Columbia | V5Z1M9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30698711 | Result | Saw J, Starovoytov A, Humphries K, Sheth T, So D, Minhas K, Brass N, Lavoie A, Bishop H, Lavi S, Pearce C, Renner S, Madan M, Welsh RC, Lutchmedial S, Vijayaraghavan R, Aymong E, Har B, Ibrahim R, Gornik HL, Ganesh S, Buller C, Matteau A, Martucci G, Ko D, Mancini GBJ. Canadian spontaneous coronary artery dissection cohort study: in-hospital and 30-day outcomes. Eur Heart J. 2019 Apr 14;40(15):1188-1197. doi: 10.1093/eurheartj/ehz007. |
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| ID | Term |
|---|---|
| C565153 | Coronary Artery Dissection, Spontaneous |
| D005352 | Fibromuscular Dysplasia |
| D009203 | Myocardial Infarction |
| D000088442 | MINOCA |
| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
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Saliva DNA sample
| During index hospitalization |
| D006331 | Heart Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |