Clinical Trial: Canadian SCAD Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Canadian Spontaneous Coronary Artery Dissection (SCAD) Cohort Study

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.

Detailed Summary:

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
Sponsor: Cardiology Research UBC

Current Primary Outcome:

  • 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)
  • 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Cardiology Research UBC

Dates:
Date Received: July 9, 2014
Date Started: June 2014
Date Completion: December 2019
Last Updated: September 24, 2015
Last Verified: September 2015