Canadian SCAD Study

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

Natural history multicenter, prospective, observational registry with 10-year follow-up

Study Overview

• Status: Recruiting
• Conditions: Spontaneous Coronary Artery Dissection; SCAD; Fibromuscular Dysplasia
• Intervention / Treatment: Genetic: Genetic sub-study

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 Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Andrew Starovoytov, MD; Phone Number: 6048755079; Email: a.starovoytov@ubc.ca
• Study Contact Backup: Name: Johandra Argote Parolis, MD; Phone Number: 63344 6048754111; Email: j.argoteparolis@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z1M9
      • Recruiting
      • Vancouver General Hospital
      • Principal Investigator: Jacqueline Saw, MD
      • Contact: Johandra Argote Parolis, MD; Phone Number: 63344 604 875 4111; Email: j.argoteparolis@ubc.ca
      • Sub-Investigator: John GB Mancini, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Single group observational study	Genetic: Genetic sub-study; One time saliva sample collection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cardiology Research UBC
• Collaborators: John GB Mancini, MD; Karin Humphries, DSc
• Investigators: Principal Investigator: Jacqueline Saw, MD, Cardiology Research UBC / Vancouver General Hospital

Publications and helpful links

General 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):1188-1197. doi: 10.1093/eurheartj/ehz007.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): December 1, 2033
• Study Completion (Anticipated): December 1, 2033

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): May 28, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Myocardial Infarction; SCAD; Fibromuscular displasia (FMD); Myocardial Infarction in women; Non-atherosclerotic coronary artery disease (NACAD); Myocardial Infarction with no obstructive coronary artery disease (MINOCA); Spontaneous Coronary Artery Dissection
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Aneurysm; Vascular Diseases; Aneurysm, Dissecting; Coronary Vessel Anomalies; Fibromuscular Dysplasia
• Other Study ID Numbers: H18-03039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No