Canadian SCAD Study

NCT04906356 | Recruiting

• 1 other identifier: H18-03039
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• In-hospital CV outcomes

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

  From date of hospital admission to discharge up to 8 weeks

• Long-term CV outcomes

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

  at 10 Years post index event

Secondary Outcomes (2)

• Arterial healing post SCAD

  at 6 weeks post discharge post index event

• Coronary revascularization success

  During index hospitalization

Study Arms (1)

Study group

Single group observational study

Genetic: Genetic sub-study

Interventions

Genetic sub-study GENETIC

One time saliva sample collection

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients admitted with ACS (STEMI, NSTEMI or unstable angina)
• Documented SCAD on a coronary angiogram (including diagnosis with OCT or IVUS)

You may not qualify if:

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

Sponsors & Collaborators

• Cardiology Research UBC: lead
• John GB Mancini, MD: collaborator
• Karin Humphries, DSc: collaborator

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 30698711 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Saliva DNA sample

MeSH Terms

Conditions

Coronary Artery Dissection, Spontaneous; Fibromuscular Dysplasia; Myocardial Infarction; MINOCA

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Jacqueline Saw, MD

  Cardiology Research UBC / Vancouver General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Starovoytov, MD

CONTACT

6048755079; a.starovoytov@ubc.ca

Johandra Argote Parolis, MD

CONTACT

6048754111; j.argoteparolis@ubc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Medicine

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: May 28, 2021
• Study Start: December 1, 2018
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): December 1, 2033
• Last Updated: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)