NCT02188069

Brief Summary

SCAD (Spontaneous coronary artery dissection - tear in the arterial wall that is not related to trauma) is an under-diagnosed and poorly understood condition that mostly affects young women without common cardiovascular risk factors, and can result in heart attack and death. This observational study is designed to capture the disease's natural history and predisposing arteriopathies (medical conditions resulting in changes in the arteries), treatment strategies, long-term cardiovascular outcomes. It will also improve the diagnosis of SCAD on coronary angiography by participating clinicians, and provide guidance on investigating predisposing conditions.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
2 countries

20 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

6 years

First QC Date

July 9, 2014

Last Update Submit

August 8, 2018

Conditions

Keywords

Non-atherosclerotic Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

  • Composite in-hospital outcome

    Composite of all-cause mortality, stroke, reinfarction (31), cardiogenic shock (requiring medical or mechanical hemodynamic support), congestive heart failure, severe ventricular arrhythmia (requiring defibrillation or antiarrhythmic agents), repeat revascularization (or unplanned revascularization), and cardiac transplantation, collectively termed in-hospital major adverse events (MAE)

    During index admission

  • Composite follow-up outcome

    Composite of all-cause mortality, stroke, recurrent MI (including recurrent dissection), congestive heart failure and repeat revascularization, collectively termed major adverse cardiac events (MACE).

    3 years post index event

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Prospective patients presenting with Spontaneous coronary artery dissection (SCAD)

You may qualify if:

  • Patients admitted with troponin-positive ACS (NSTEMI or STEMI)
  • Documented NA-SCAD on coronary angiogram (including diagnosis with OCT or IVUS)

You may not qualify if:

  • Patients with troponin-negative ACS
  • Patients with typical atherosclerotic coronary artery disease in other coronary arterial segments with diameter stenosis ≥50%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Location

University of Alberta

Edmonton, Alberta, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Saint Boniface General Hospital

Winnipeg, Manitoba, Canada

Location

Queen Elizabeth Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

Hamilton Health Sciences General Site

Hamilton, Ontario, Canada

Location

Saint Mary's

Kitchener, Ontario, Canada

Location

London Health Sciences

London, Ontario, Canada

Location

Southlake Regional Hospital

Newmarket, Ontario, Canada

Location

Ottawa Heart Institute

Ottawa, Ontario, Canada

Location

Rough Valley Health System

Scarborough Village, Ontario, Canada

Location

Saint Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

McGill University Health Centre (CUSM)

Montreal, Quebec, Canada

Location

Montreal Heart Institute

Montreal, Quebec, Canada

Location

University of Montreal (CHUM)

Montreal, Quebec, Canada

Location

Regina General Hospital

Regina, Saskatchewan, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Location

Related Publications (4)

  • Saw J. Coronary angiogram classification of spontaneous coronary artery dissection. Catheter Cardiovasc Interv. 2014 Dec 1;84(7):1115-22. doi: 10.1002/ccd.25293. Epub 2013 Dec 4.

    PMID: 24227590BACKGROUND
  • Saw J, Poulter R, Fung A, Wood D, Hamburger J, Buller CE. Spontaneous coronary artery dissection in patients with fibromuscular dysplasia: a case series. Circ Cardiovasc Interv. 2012 Feb 1;5(1):134-7. doi: 10.1161/CIRCINTERVENTIONS.111.966630. No abstract available.

    PMID: 22338003BACKGROUND
  • Saw J, Ricci D, Starovoytov A, Fox R, Buller CE. Spontaneous coronary artery dissection: prevalence of predisposing conditions including fibromuscular dysplasia in a tertiary center cohort. JACC Cardiovasc Interv. 2013 Jan;6(1):44-52. doi: 10.1016/j.jcin.2012.08.017. Epub 2012 Dec 19.

    PMID: 23266235BACKGROUND
  • Saw J, Aymong E, Mancini GB, Sedlak T, Starovoytov A, Ricci D. Nonatherosclerotic coronary artery disease in young women. Can J Cardiol. 2014 Jul;30(7):814-9. doi: 10.1016/j.cjca.2014.01.011. Epub 2014 Jan 23.

    PMID: 24726091BACKGROUND

MeSH Terms

Conditions

Coronary Artery Dissection, Spontaneous

Study Officials

  • Jacqueline Saw, MD

    Vancouver General Hospital, University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research

Study Record Dates

First Submitted

July 9, 2014

First Posted

July 11, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2020

Study Completion

December 1, 2020

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations