Association of Lipid Core Plaque With Subsequent Clinical Outcomes: a Collaborative Near-infrared Spectroscopy Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 5
- 主要终点
- Incidence of major adverse cardiac events
研究概览
简要总结
This is a multi-center, investigator initiated study that will prospectively examine treatment strategies and outcomes of patients who underwent clinically-indicated Near Infrared Spectroscopy (NIRS). The information collected will be used to determine the frequency of NIRS imaging performed at the participating sites and to examine the clinical outcomes of the NIRS-detected Lipid Core Plaques (LCPs).
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 who have undergone/ will be undergoing NIRS imaging at each of the participating centers.
排除标准
- 未提供
结局指标
主要结局
Incidence of major adverse cardiac events
时间窗: 1 to 15 years following clinically indicated Near InfraRed Spectroscopy imaging
The primary endpoint for both hypotheses is the incidence of major adverse cardiac events. Major adverse cardiac events include the following: * cardiac death * cardiac arrest * acute coronary syndrome * stent thrombosis, repeat coronary angiography * coronary revascularization (either by percutaneous coronary intervention or coronary artery bypass graft surgery). * rehospitalization for progressive angina, attributed to a non-culprit lesion secondary to significant fixed, non-reversible (not-spasm related) lesion progression of more than 20% from the baseline study (confirmed by either serial angiography or by necropsy). Events will be classified as events occurring at the site of stent implantation and events occurring at previously untreated lesions. Moreover, analyses will be performed on a per patient and per LCP basis.
次要结局
未报告次要终点