Canadian SCAD Study

Spontaneous Coronary Artery Dissection Clinical Trial

Official title:

Canadian Spontaneous Coronary Artery Dissection (SCAD) Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02188069
• Other study ID #: H14-00968
• Status: Active, not recruiting
• Start date: June 2014
• Est. completion date: December 2020

Study information

• Verified date: August 2018
• Source: Cardiology Research UBC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 750
• Est. completion date: December 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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%

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Spontaneous Coronary Artery Dissection

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Cardiology Research UBC	Canadian Institutes of Health Research (CIHR)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (4)

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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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