Norwegian Spontaneous Coronary Artery Dissection Study (NOR-SCAD Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Major Adverse Cardiac Events
研究概览
简要总结
The Norwegian Spontaneous Coronary Artery Dissection Study (NOR-SCAD) is a national, multicenter prospective observational study conducted at major hospitals in Norway. The study investigates risk factors and complications of spontaneous coronary artery dissection (SCAD). Patients aged 18 years or older who are hospitalized with SCAD are recruited during the index hospitalization. Each participant will be followed for 52 weeks with scheduled visits at 8 and 12 weeks and a final phone call at 52 weeks. Evaluations include coronary CT angiography (CTA), cardiac assessments, genetic analyses, blood sampling, structured questionnaires, and a cardiopulmonary exercise test (CPET).
详细描述
Background: SCAD has emerged as an important cause of myocardial infarction, especially among women under 60 years of age, and is a leading cause of pregnancy-related myocardial infarction. Despite increased awareness over the past two decades, SCAD remains under-recognized, and management varies widely because of limited evidence. Key gaps persist in understanding SCAD etiology, precipitating factors, optimal diagnostic follow-up (including the role of CTA), and the incidence of complications.
Objectives:
Primary objectives: Determine the incidence and types of complications and major adverse cardiac events (MACE) within the first year after SCAD.
Secondary objectives: Evaluate the diagnostic and follow-up utility of coronary CTA.
Methods:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spontaneous coronary artery dissection
排除标准
- •Severe kidney failure
- •Severe allergic reaction to contrast
研究组 & 干预措施
Prospective
SCAD
结局指标
主要结局
Major Adverse Cardiac Events
时间窗: From enrollment to the end of follow-up at 52 weeks
Recurrent myocardial infarction, extra coronary dissection, stroke/TIA, heart failure,
次要结局
- Assessment of Quality of life(12 weeks after event)
- CTA(Acute and after 12 weeks)
研究者
Mette-Elise Estensen
MD, PhD, Consultant Cardiologist
Oslo University Hospital