Chemometric Observation of Lipid Core Plaques of Interest in Native Coronary Arteries Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,067
- 试验地点
- 22
- 主要终点
- Identify associations of LCP with angiographic or symptomatic presentation of coronary artery disease in a catheterization laboratory population
研究概览
简要总结
In April 2008, a coronary catheter based imaging system, LipiScan, was cleared by the FDA for use in detecting lipid core containing containing plaques of interest (LCP). These plaques are rich in cholesterol. The way that cholesterol and other lipids deposit with the coronary artery is unique to each patient. This study is an organized attempt to observe the LCP and the variety of ways that it presents in patients as detected by this recently approved device. This information will be used for physician training and to observe the behavior of the LCP in response to no therapy and currently approved therapies. The purpose of this project is further medical knowledge of the LCP and its treatment.
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
- •Subject is at least 18 years of age.
- •Subject is scheduled for elective coronary catheterization.
- •LipiScan CIS, LipiScan IVUS Imaging System, or TVC Imaging System use is not contra-indicated.
- •At least one chemogram from a native coronary artery is available for submission to the registry.
- •Able to read, understand and sign the informed consent.
排除标准
- •Subject is pregnant or nursing.
- •Subject life expectancy is less than 2 years at time of index catheterization.
- •All submitted chemograms are obtained with the LipiScan, LipiScan IVUS, or TVC(R) Imaging Catheter positioned within a coronary artery bypass graft.
- •Unable to give informed consent
结局指标
主要结局
Identify associations of LCP with angiographic or symptomatic presentation of coronary artery disease in a catheterization laboratory population
时间窗: after completion of the study - during data analysis
次要结局
- Identification of associations that LCP or the Lipid Core Burden Index (LCBI) may have with atherosclerosis appearance, progression, regression, and/or cardiac event(Upto 2 years post procedure(baseline))