Identification of Risk Factors for Acute Coronary Events by Optical Coherence Tomography After STEMI and NSTEMI in Patients With Residual Non-flow Limiting Lesions The 'PECTUS-obs' Trial (Observational Cohort)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 438
- 试验地点
- 2
- 主要终点
- Major Adverse Cardiac Events
研究概览
简要总结
The objective of this study is to compare the clinical outcome of Non-ST-elevation myocardial infarction (NSTEMI) and ST-elevation myocardial infarction (STEMI) patients with non-obstructive, non-culprit coronary lesions and either presence or absence of vulnerable plaque characteristics as assessed by optical coherence tomography (OCT).
详细描述
Despite major advances in the treatment of acute coronary syndromes a large proportion of patients is still at risk for new coronary events after experiencing an acute coronary syndrome (ACS). Detection of residual vulnerable plaques after ACS using OCT potentially identifies patients at high risk for new coronary events. However, no prospectively collected data on the prognostic power of OCT for plaque rupture are available at this moment. To design trials aimed to reduce events in patients with vulnerable plaques it is required to collect such prospective data on the relation between OCT derived characteristics of vulnerability and clinical outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Informed consent must be obtained.
- •Patients with STEMI or NSTEMI and residual, non-culprit CAD, with the possibility of plaque vulnerability.
- •Residual plaque(s) is(are) non-obstructive (FFR≥0.80).
排除标准
- •Refusal or inability to provide informed consent.
- •< 18 years of age
- •Hemodynamic instability, respiratory failure, Kilip class ≥
- •Previous Coronary Artery Bypass Grafting (CABG).
- •Indication for revascularization by CABG.
- •Anatomy or lesions unsuitable for OCT catheter crossing or imaging (aorta-ostial lesions, small diameter segment, severe calcifications, lesion is too distal for OCT catheter)
- •Pregnancy.
- •Estimated life expectancy < 3 year
结局指标
主要结局
Major Adverse Cardiac Events
时间窗: 2 years
Composite of all cause mortality, non-fatal myocardial infarction or unplanned revascularization.
次要结局
- Target lesion Failure(2 and 5 years)
- Major Adverse Cardiac Events(5 years)