The Massachusetts General Hospital Optical Coherence Tomography Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,714
- 试验地点
- 1
- 主要终点
- Major adverse cardiac events (MACE)
研究概览
简要总结
Information will be collected prospectively in about 3,000 patients having Optical Coherence Tomography during cardiac catheterization. Subjects will be initially enrolled at sites outside of the United States, where Optical Coherence Tomography is approved by regulatory agencies. Subjects will be followed for up to 5 years.
详细描述
This project will create a prospective registry of 3,000 patients with follow-ups of up to 5 years.
The aims of the project will be:
- identify plaque characteristics on OCT that are associated with adverse cardiac events including myocardial infarction
- to identify characteristics of stented arteries that are associated with adverse events including restenosis and stent thrombosis
Because detailed clinical, angiographic and intravascular imaging data will be gathered from a large number of patients with clinical follow-ups, we anticipate that the registry will be a tremendous resource for additional research questions going forward.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Subjects who have had OCT imaging performed during cardiac catheterization and have provided written consent
排除标准
- 未提供
结局指标
主要结局
Major adverse cardiac events (MACE)
时间窗: 1 year
次要结局
未报告次要终点
研究者
Ik-Kyung Jang, MD, PhD
Professor of Medicine; Director, Cardiology Laboratory for Integrative Physiology & Imaging
Massachusetts General Hospital