Canadian Spontaneous Coronary Artery Dissection (SCAD) Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 750
- 试验地点
- 20
- 主要终点
- Composite in-hospital outcome
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted with troponin-positive ACS (NSTEMI or STEMI)
- •Documented NA-SCAD on coronary angiogram (including diagnosis with OCT or IVUS)
排除标准
- •Patients with troponin-negative ACS
- •Patients with typical atherosclerotic coronary artery disease in other coronary arterial segments with diameter stenosis ≥50%
结局指标
主要结局
Composite in-hospital outcome
时间窗: 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
时间窗: 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).
次要结局
未报告次要终点
研究者
Jacqueline Saw, MD
Director of Research
Cardiology Research UBC