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Canadian SCAD Study

NCT ID: NCT04906356

Last Updated: 2021-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2033-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Spontaneous Coronary Artery Dissection SCAD Fibromuscular Dysplasia

Keywords

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

Single group observational study

Genetic sub-study

Intervention Type GENETIC

One time saliva sample collection

Interventions

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Genetic sub-study

One time saliva sample collection

Intervention Type GENETIC

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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John GB Mancini, MD

UNKNOWN

Sponsor Role collaborator

Karin Humphries, DSc

UNKNOWN

Sponsor Role collaborator

Cardiology Research UBC

OTHER

Sponsor Role lead

Responsible Party

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Jacqueline Saw, MD

Clinical Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jacqueline Saw, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiology Research UBC / Vancouver General Hospital

Locations

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Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Andrew Starovoytov, MD

Role: CONTACT

Phone: 6048755079

Email: [email protected]

Johandra Argote Parolis, MD

Role: CONTACT

Phone: 6048754111

Email: [email protected]

Facility Contacts

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Johandra Argote Parolis, MD

Role: primary

References

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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.

Reference Type RESULT
PMID: 30698711 (View on PubMed)

Other Identifiers

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H18-03039

Identifier Type: -

Identifier Source: org_study_id