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NCT Number: NCT04906356

Canadian SCAD Study

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

Location status: Recruiting

Location contact

Jacqueline Saw, MD

PRINCIPAL_INVESTIGATOR

Johandra Argote Parolis, MD

CONTACT

[email protected]

604 875 4111 ext. 63344

John GB Mancini, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Patients where SCAD is attributed to atherosclerotic coronary artery disease, with atherosclerotic coronary artery disease stenosis ≥50%

Treatment and study plan

Genetic sub-study

Genetic

One time saliva sample collection

Primary outcomes

  1. 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)

  2. Long-term CV outcomes

    Time frame: at 10 Years post index event

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

Secondary outcomes

  1. Arterial healing post SCAD

    Time frame: at 6 weeks post discharge post index event

    Angiographic healing

  2. Coronary revascularization success

    Time frame: During index hospitalization

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

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Starovoytov, MD

CONTACT

[email protected]

6048755079

Johandra Argote Parolis, MD

CONTACT

[email protected]

6048754111 ext. 63344

Sponsors and collaborators

Lead sponsor

Cardiology Research UBC

Other

Collaborators

  • John GB Mancini, MD
  • Karin Humphries, DSc

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2033
Study completion
2033
First posted
May 28, 2021
Registry last updated
May 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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