NCT02803411进行中（未招募）不适用
Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography Imaging(PARADIGM)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
- 主要终点
- Change in plaque volume and composition detected by follow up CCTA
研究概览
简要总结
To describe the natural history of the coronary atherosclerotic plaque development and progression over time by CCTA with demographic and laboratory data for refinement of risk stratification of patients referred for CCTA.
详细描述
All PARADIGM study patients underwent initial and follow-up CCTA based on order from their primary physician. Demographic data, targeted medical history, cardiovascular risk factors, and laboratory data was prospectively collected in electronic case report forms (eCRFs) at the time of the initial CCTA and at the time of follow-up CCTA.
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
- •patients underwent two or more clinically indicated CCTA with 64-detector rows or greater for CAD evaluation
- •patients underwent at least 2 year interval between the baseline and follow-up CCTA
排除标准
- •poor image quality of CCTA
结局指标
主要结局
Change in plaque volume and composition detected by follow up CCTA
时间窗: 2 years
次要结局
- Myocardial infarction (yes or no)(2 years)
- Revascularization (yes or no)(2 years)
- Cardiac mortality (yes or no)(2 years)
- Unstable angina requiring hospitalization (yes or no)(2 years)
研究者
Hyuk-Jae Chang
Professor
Yonsei University
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