Clinical trial NCT04906356: Canadian SCAD Study
Official title: Canadian Spontaneous Coronary Artery Dissection (SCAD) Study and Genetic Sub-study (Prospective, Observational Registry With 10 Year Follow-up)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spontaneous Coronary Artery Dissection
SCAD
Fibromuscular Dysplasia
Keywords: 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
Lead sponsor: Cardiology Research UBC
Sponsor class: OTHER
Collaborators: name: John GB Mancini, MD
name: Karin Humphries, DSc
First posted: 2021-05-28
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients admitted with ACS (STEMI, NSTEMI or unstable angina)
2. 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%

Primary outcomes:
measure: In-hospital CV outcomes
timeFrame: From date of hospital admission to discharge up to 8 weeks
measure: Long-term CV outcomes
timeFrame: at 10 Years post index event
Secondary outcomes:
measure: Arterial healing post SCAD
timeFrame: at 6 weeks post discharge post index event
measure: Coronary revascularization success
timeFrame: During index hospitalization
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: Cardiology Research UBC / Vancouver General Hospital
name: Jacqueline Saw, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.