CClinicalTrials.gg
RecruitingNCT04906356Updated May 28, 2021

Canadian SCAD Study

An observational study in Spontaneous Coronary Artery Dissection, SCAD and Fibromuscular Dysplasia, sponsored by Cardiology Research UBC. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-28.

Sponsored by Cardiology Research UBC · Observational

From the registry’s dates

  • Started Dec 2018; still recruiting 7 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • 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
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In context

Aortic Dissection

386 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 183 across 180 observational studies indexed under Aortic Dissection.

Browse Aortic Dissection studies →

Lead sponsor

Cardiology Research UBC is the lead sponsor of 18 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  1. Patients where SCAD is attributed to atherosclerotic coronary artery disease, with atherosclerotic coronary artery disease stenosis ≥50%
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Study group

    Single group observational study

    Genetic: Genetic sub-study

Interventions

  • GeneticGenetic sub-study

    One time saliva sample collection

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What researchers measure

Primary outcomes

  1. In-hospital CV outcomes

    Composite (Death, MI, CVA, Unplanned revascularization, Heart failure)

    Time frame: From date of hospital admission to discharge up to 8 weeks

  2. Long-term CV outcomes

    Composite (Death, MI, CVA, Revascularization, Heart failure)

    Time frame: at 10 Years post index event

Secondary outcomes

  1. Arterial healing post SCAD

    Angiographic healing

    Time frame: at 6 weeks post discharge post index event

  2. Coronary revascularization success

    Composite (TIMI 3 flow, \<50% stenosis, and no residual dissection)

    Time frame: During index hospitalization

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Study locations

1 of 1 sites recruiting
  • Vancouver General Hospital
    Vancouver, British Columbia V5Z1M9, Canada
    • Johandra Argote Parolis, MD · Contact · j.argoteparolis@ubc.ca · 604 875 4111
    • Jacqueline Saw, MD · Principal investigator
    • John GB Mancini, MD · Sub investigator
    Recruiting
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References and documents

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. PubMed 30698711 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04906356
Lead sponsor
Cardiology Research UBC
Collaborators
John GB Mancini, MD, Karin Humphries, DSc
Responsible party
Jacqueline Saw, MD (Clinical Professor of Medicine, Cardiology Research UBC) — Principal investigator
First posted
May 28, 2021
Start date
Dec 1, 2018
Primary completion
Dec 1, 2033 (estimated)
Completion
Dec 1, 2033 (estimated)
Last update
May 28, 2021

Study contacts

Andrew Starovoytov, MD
Contact
a.starovoytov@ubc.ca
6048755079
Johandra Argote Parolis, MD
Contact
j.argoteparolis@ubc.ca
6048754111 ext. 63344
Jacqueline Saw, MD
principal investigator · Cardiology Research UBC / Vancouver General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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