Canadian SCAD Study

Recruiting

• Conditions: SCAD; Fibromuscular Dysplasia; Spontaneous Coronary Artery Dissection
• Interventions: Genetic: Genetic sub-study

• Registration Number: NCT04906356
• Lead Sponsor: Cardiology Research UBC

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.

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2021-04-16
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-25
• Last Update Submitted: 2021-05-25
• Study First Posted: 2021-05-28
• Last Update Posted: 2021-05-28
• Primary Completion: 2033-12-01
• Study Completion: 2033-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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%

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Genetic sub-study	Single group observational study

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Coronary revascularization success	During index hospitalization	Composite (TIMI 3 flow, \<50% stenosis, and no residual dissection)
Arterial healing post SCAD	at 6 weeks post discharge post index event	Angiographic healing

Trial Locations

Locations (1)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada