- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04906356
Canadian SCAD Study
Canadian Spontaneous Coronary Artery Dissection (SCAD) Study and Genetic Sub-study (Prospective, Observational Registry With 10 Year Follow-up)
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
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
-
-
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
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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%
Study Plan
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
Sponsor
Investigators
- Principal Investigator: Jacqueline Saw, MD, Cardiology Research UBC / Vancouver General Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H18-03039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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