Canadian SCAD Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Genetic sub-study.
- Who it may be relevant to
- Registry conditions: Spontaneous Coronary Artery Dissection, SCAD, Fibromuscular Dysplasia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Canadian Spontaneous Coronary Artery Dissection (SCAD) Study and Genetic Sub-study (Prospective, Observational Registry With 10 Year Follow-up)
Overview
Natural history multicenter, prospective, observational registry with 10-year follow-up
Detailed description
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.
Interventions
- Genetic Genetic sub-study
One time saliva sample collection
Primary outcome measures
- In-hospital CV outcomes [Time frame: From date of hospital admission to discharge up to 8 weeks]
- Long-term CV outcomes [Time frame: at 10 Years post index event]
Secondary outcome measures (2)
- Arterial healing post SCAD [Time frame: at 6 weeks post discharge post index event]
- Coronary revascularization success [Time frame: During index hospitalization]
Eligibility criteria
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%
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Vancouver General Hospital — Vancouver
Publications
- 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):118 PMID 30698711
Identifiers
NCT: NCT04906356 · H18-03039