Canadian SCAD Study

August 8, 2018 updated by: Jacqueline Saw, MD, Cardiology Research UBC

Canadian Spontaneous Coronary Artery Dissection (SCAD) Cohort Study

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

Background:

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 been inadequately researched, with no prospective studies evaluating management strategies, assessing the presence and impact of predisposing and precipitating causes, or assessing its effects on short- and long-term CV prognosis. Furthermore, many people presenting with MI due to SCAD have been mis-diagnosed due to the limitations of the current "gold-standard" diagnostic test (coronary angiography) for this condition, resulting in erroneous diagnoses such as atherosclerosis, microvascular dysfunction, Takotsubo cardiomyopathy, coronary artery spasm, or "normal" coronary arteries. As such, clinicians are uncertain about how to diagnose, investigate and manage patients with SCAD, and similarly, patients are uncertain about how this condition will affect their subsequent lifestyle and long-term cardiac prognosis. Therefore, we propose a large prospective multicenter Canadian SCAD cohort study to ascertain the natural history according to predisposing arteriopathies and treatment strategy on long-term CV outcomes. The design of this study will secondarily improve the diagnosis of SCAD on coronary angiography by participating clinicians, and provide guidance on investigating predisposing conditions.

Preliminary Data:

We have enrolled 170 NA-SCAD patients in our registry at Vancouver General Hospital. We discovered a very strong association between NA-SCAD and fibromuscular dysplasia (FMD), with ~80% of these NA-SCAD patients diagnosed with concomitant FMD. Of patients who underwent coronary angioplasty/stenting, successful and durable results occurred in only 33%. Of patients treated medically, those who had repeat coronary angiograms all showed angiographic healing.

Primary Objective:

  1. To evaluate the overall natural history of NA-SCAD: (a) the overall in-hospital and long-term CV outcomes with NA-SCAD, (b) the prevalence and effects of predisposing arteriopathies on in-hospital and long-term CV outcomes, (c) the prevalence and impact of precipitating stressors on in-hospital and long-term CV events.

    Secondary Objectives:

  2. To evaluate the in-hospital and long-term outcomes of conservative therapy and revascularization in patients with NA-SCAD.
  3. To evaluate the presenting angiographic patterns of NA-SCAD.
  4. To assess the incidence of spontaneous arterial healing with conservative medical therapy alone in NA-SCAD patients undergoing repeat angiography.

Hypotheses:

  1. We hypothesize that NA-SCAD patients have a high risk of long-term recurrent CV events and FMD, as the most frequently observed predisposing condition confers lower subsequent risk compared to other arteriopathies, such as peripartum SCAD, with regards to CV outcomes. We hypothesize that precipitating stressors are common preceding the SCAD event in >50% of cases.
  2. We hypothesize that NA-SCAD patients have a high risk of long-term CV events, and that patients who undergo revascularization have worse CV outcomes.
  3. We hypothesize that the most common angiographic NA-SCAD pattern is diffuse stenosis.
  4. We hypothesize that conservative medical therapy is associated with high rates of spontaneous healing.

Methodology:

Prospective Canadian observational cohort study enrolling 750 consecutive patients presenting with MI (NSTEMI or STEMI) due to NA-SCAD. Both women and men will be included. Rigorous coronary angiographic criteria with supplementary intracoronary imaging (reviewed by core laboratory) will be used for SCAD diagnosis. Detailed baseline demographics, targeted history for predisposing and precipitating factors, and screening laboratory tests will be performed. Patients will be prospectively followed for 3 years for CV events.

Significance:

This study will have significant impacts on the diagnosis, investigation, and management of NA-SCAD. Our diagnostic algorithm will help establish guidelines on SCAD diagnosis on coronary angiogram, which is currently elusive. Our rigorous clinical and laboratory screening will elucidate the prevalence of predisposing arteriopathies, which will help establish guidelines on investigation of SCAD patients. Knowledge of CV outcomes and natural history of NA-SCAD, especially stratified to predisposing arteriopathies, will establish prognosis, risk stratification, and management guidelines.

Knowledge Translation:

Our results will be disseminated to clinicians and patients through publications in scientific journals, physician scientific presentations, Healthy Heart Programs, patient educational sessions, educational website, and public media. Results from this study will help establish national and international guidelines on the diagnosis, investigation and management of NA-SCAD.

Study Type

Observational

Enrollment (Actual)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Royal Alexandra Hospital
      • Edmonton, Alberta, Canada
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Vancouver General Hospital
      • Vancouver, British Columbia, Canada
        • St. Paul's Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Saint Boniface General Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Queen Elizabeth Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Canada
        • Hamilton Health Sciences General Site
      • Kitchener, Ontario, Canada
        • Saint Mary's
      • London, Ontario, Canada
        • London Health Sciences
      • Newmarket, Ontario, Canada
        • Southlake Regional Hospital
      • Ottawa, Ontario, Canada
        • Ottawa Heart Institute
      • Scarborough, Ontario, Canada
        • Rough Valley Health System
      • Toronto, Ontario, Canada
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada
        • Saint Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • Montreal Heart Institute
      • Montreal, Quebec, Canada
        • McGill University Health Centre (CUSM)
      • Montreal, Quebec, Canada
        • University of Montreal (CHUM)
    • Saskatchewan
      • Regina, Saskatchewan, Canada
        • Regina General Hospital
      • Saskatoon, Saskatchewan, Canada
        • Royal University Hospital
  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Prospective patients presenting with Spontaneous coronary artery dissection (SCAD)

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
During index admission
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).
3 years post index event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiology Research UBC

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Jacqueline Saw, MD, Vancouver General Hospital, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

July 9, 2014

First Submitted That Met QC Criteria

July 9, 2014

First Posted (Estimate)

July 11, 2014

Study Record Updates

Last Update Posted (Actual)

August 10, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H14-00968

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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