Canadian SCAD Study

Spontaneous Coronary Artery Dissection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04906356
• Other study ID #: H18-03039
• Status: Recruiting
• Start date: December 1, 2018
• Est. completion date: December 1, 2033

Study information

• Verified date: May 2021
• Source: Cardiology Research UBC
• Contact: Andrew Starovoytov, MD
• Phone: 6048755079
• Email: a.starovoytov[@]ubc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 1, 2033
• Est. primary completion date: December 1, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Coronary Vessel Anomalies
• Fibromuscular Dysplasia
• SCAD
• Spontaneous Coronary Artery Dissection
• Vascular Diseases

Intervention

Genetic:
• Genetic sub-study
One time saliva sample collection

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Cardiology Research UBC	John GB Mancini, MD, Karin Humphries, DSc

Country where clinical trial is conducted

Canada, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital CV outcomes	Composite (Death, MI, CVA, Unplanned revascularization, Heart failure)	From date of hospital admission to discharge up to 8 weeks
Primary	Long-term CV outcomes	Composite (Death, MI, CVA, Revascularization, Heart failure)	at 10 Years post index event
Secondary	Arterial healing post SCAD	Angiographic healing	at 6 weeks post discharge post index event
Secondary	Coronary revascularization success	Composite (TIMI 3 flow, <50% stenosis, and no residual dissection)	During index hospitalization