Canadian SCAD Study

May 25, 2021 updated by: Jacqueline Saw, MD, Cardiology Research UBC

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
        • Recruiting
        • Vancouver General Hospital
        • Principal Investigator:
          • Jacqueline Saw, MD
        • Contact:
        • Sub-Investigator:
          • John GB Mancini, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Single group observational study
One time saliva sample collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital CV outcomes
Time Frame: From date of hospital admission to discharge up to 8 weeks
Composite (Death, MI, CVA, Unplanned revascularization, Heart failure)
From date of hospital admission to discharge up to 8 weeks
Long-term CV outcomes
Time Frame: at 10 Years post index event
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
Time Frame: at 6 weeks post discharge post index event
Angiographic healing
at 6 weeks post discharge post index event
Coronary revascularization success
Time Frame: During index hospitalization
Composite (TIMI 3 flow, <50% stenosis, and no residual dissection)
During index hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jacqueline Saw, MD, Cardiology Research UBC / Vancouver General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spontaneous Coronary Artery Dissection

Clinical Trials on Genetic sub-study

Subscribe