The International Spontaneous Coronary Artery Dissection "iSCAD" Registry (SCAD)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
- 试验地点
- 62
- 主要终点
- Descriptive Data
研究概览
简要总结
The aim of "iSCAD," the International Spontaneous Coronary Artery Dissection (SCAD) Registry, is to serve as an internationally collaborative, multicenter registry coordinated by an experienced and centralized coordinating center in an effort to increase the pace of participant recruitment, and thereby increase statistical power of studies related to SCAD.
The ultimate goal of iSCAD Registry is to facilitate the development of best practices and clinical guidelines for preventing SCAD or its recurrence. This observational study will be prospective and retrospective in its recruitment and will collect clinical information to better understand the natural history and prognosis for SCAD.
详细描述
Spontaneous Coronary Artery Dissection (SCAD) is an under-diagnosed cause of acute coronary syndrome (ACS), myocardial infarction (MI) and sudden cardiac arrest. The inner lining of the coronary artery splits and allows blood to seep into the adjacent layer, forming a blockage (hematoma), or the artery continues to tear, creating a flap of tissue that blocks blood flow in the artery.
SCAD strikes generally healthy, younger individuals (average age 42) who do not have traditional cardiac risk factors. Warning signs of SCAD encompass the full range of ACS and MI symptoms, from vague to classic. The cause of SCAD is currently unknown and the psychosocial impact of SCAD is traumatizing. The work of the iSCAD Registry will encompass the physical and psychosocial study of SCAD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Participants with a new diagnosis of SCAD or a history of confirmed or suspected SCAD will be prospectively recruited from either:
- •Inpatient wards of the enrolling medical centers during the acute presentation of SCAD, or
- •Outpatient cardiovascular clinics of enrolling medical centers.
- •Participants must be:
- •18 years of age or older
- •Diagnosis of SCAD or history of SCAD based on coronary angiography, either catheter-based or coronary CTA
- •Suspected SCAD by coronary angiography
排除标准
- •Coronary dissection in association with atherosclerosis or as a result of iatrogenic injury
- •Inability to provide informed consent
- •Inability to complete study-related patient questionnaires
- •Inability to understand and complete patient questionnaires independently
结局指标
主要结局
Descriptive Data
时间窗: Continuous time frame following index event for an average of 3 years from study contact date
Participant demographic, historical, clinical characteristics, and treatment data
Clinical Outcomes
时间窗: Continuous time frame following index event for an average of 3 years from study contact date
Prospectively collected long-term outcomes including recurrent myocardial infarction, hospitalization, heart failure, stroke or transient ischemic attack, arrhythmia, and all cause mortality
Psychosocial Outcomes
时间窗: Continuous time frame following index event for an average of 3 years from study contact date
Prospectively collected data on participant's mental health using validated questionnaires
次要结局
未报告次要终点