Clinical trial NCT02188069: Canadian SCAD Study
Official title: Canadian Spontaneous Coronary Artery Dissection (SCAD) Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spontaneous Coronary Artery Dissection
Keywords: Non-atherosclerotic Coronary Artery Disease
Lead sponsor: Cardiology Research UBC
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2014-07-11
Enrollment: 750
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prospective patients presenting with Spontaneous coronary artery dissection (SCAD)

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 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.

Eligibility 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%

Primary outcomes:
measure: Composite in-hospital outcome
timeFrame: During index admission
measure: Composite follow-up outcome
timeFrame: 3 years post index event
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Saint Boniface General Hospital
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences General Site
state: Ontario
city: Kitchener
country: Canada
facility: Saint Mary's
state: Ontario
city: London
country: Canada
facility: London Health Sciences
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Heart Institute
state: Ontario
city: Scarborough
country: Canada
facility: Rough Valley Health System
state: Ontario
city: Toronto
country: Canada
facility: Saint Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre (CUSM)
state: Quebec
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: University of Montreal (CHUM)
state: Quebec
city: Regina
country: Canada
facility: Regina General Hospital
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: Vancouver General Hospital, University of British Columbia
name: Jacqueline Saw, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.