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Canadian SCAD Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02188069
Recruitment Status : Active, not recruiting
First Posted : July 11, 2014
Last Update Posted : August 10, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Jacqueline Saw, MD, Cardiology Research UBC

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.

Condition or disease
Spontaneous Coronary Artery Dissection

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Study Type : Observational [Patient Registry]
Actual Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Canadian Spontaneous Coronary Artery Dissection (SCAD) Cohort Study
Study Start Date : June 2014
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Composite in-hospital outcome [ Time Frame: During index admission ]
    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)

  2. Composite follow-up outcome [ Time Frame: 3 years post index event ]
    Composite of all-cause mortality, stroke, recurrent MI (including recurrent dissection), congestive heart failure and repeat revascularization, collectively termed major adverse cardiac events (MACE).



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Prospective patients presenting with Spontaneous coronary artery dissection (SCAD)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188069


Locations
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Sponsors and Collaborators
Cardiology Research UBC
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Jacqueline Saw, MD Vancouver General Hospital, University of British Columbia
Additional Information:

Publications:
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Responsible Party: Jacqueline Saw, MD, Director of Research, Cardiology Research UBC
ClinicalTrials.gov Identifier: NCT02188069    
Other Study ID Numbers: H14-00968
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Keywords provided by Jacqueline Saw, MD, Cardiology Research UBC:
Non-atherosclerotic Coronary Artery Disease
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases