Relationship Between Coronary Plaque Morphology of Left Anterior Descending Artery and Long Term Clinical Outcome: the CLIMA Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,003
- 试验地点
- 14
- 主要终点
- Major adverse cardiac events
研究概览
简要总结
The multicenter observational CLIMA registry has been conceived to explore correlation between OCT morphology of atherosclerotic plaques located in the left anterior descending artery with mid and long term clinical outcome.
详细描述
Acute myocardial infarction (MI) is commonly caused by plaque ulceration and subsequent local thrombosis. Plaques that tend to rupture are typically characterized by a large superficial lipid pool, delimited by a thin fibrous cap and often exhibit local signs of inflammation. Such atherosclerotic lesions are commonly described as vulnerable plaques (1-4).
Identification of these plaque features with imaging modalities is potentially a valid approach to identify patients at increased risk of M (5). Optical coherence tomography is capable of visualizing superficial plaque components at a high resolution (in the range of 10-15 microns) and can depict all the features of plaque vulnerability or thrombogenicity (6,7).
The aim of the study is to relate presence of multiple OCT criteria of plaque vulnerability with following clinical events in a subset of coronary lesions. For this purpose all plaques in the proximal-mid portion of the left anterior descending artery will be evaluated with FD-OCT assessing the following criteria:
- minimum lumen area (MLA) <3.5 mm2:
- fibrous cap minimum thickness <75 µm:
- lipid arc extension >180°;
- presence of macrophages;
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years;
- •Patients with clinical indication to coronary angiography undergoing OCT evaluation of the left anterior descending artery regardless of the clinical syndrome;
- •Patients with at least 30 mm of naïve OCT-assessable proximal-mid left anterior descending artery;
- •Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent to the procedure;
排除标准
- •Female with childbearing potential or lactating;
- •Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl);
- •Advanced heart failure (NYHA III-IV)
- •Previous Coronary artery by-pass surgery
- •Previous stenting of proximal-mid left anterior descending artery with residual untreated segment <30mm.
- •Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;
- •Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;
- •Heavily calcified vessel and/or lesion which cannot be successfully imaged by OCT
结局指标
主要结局
Major adverse cardiac events
时间窗: 1-year
Composite of cardiac death and/or target vessel myocadial infarction
次要结局
- Major adverse cardiac events(3-year)
研究者
Francesco Prati
Dr.
San Giovanni Addolorata Hospital