Clinical Significance of Stress-MRI Evaluation of Right Coronary Artery Chronic Total Occlusion Recanalization Efficacy in Patients With Coronary Artery Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Stress-MRI evaluation
研究概览
简要总结
The hypothesis of this study is that Stress-MRI is a clinically significant method of myocardial perfusion assessment after coronary angioplasty with stenting of right coronary artery (RCA) chronic total occlusion (CTO) is performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable angina, CCS FC II-IV
- •"Right-dominance" coronary circulation according to coronary angiography
- •Absence of other significant atherosclerotic coronary lesions (more than 65%)
- •High risk of myocardium ischemia according to stress-MRI data (perfusion defect in 2 or more segments in the area of interest)
- •Signed, documented informed consent prior to admission to the study
排除标准
- •Acute coronary syndrome
- •Contraindications for adenosine stress test
- •Low and moderate risk of myocardium ischemia according to stress-MRI data (perfusion defect in less than 2 segments in the area of interest)
研究组 & 干预措施
Stress-MRI + Chronic total occlusion PCI
Pre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Coronary angioplasty with stenting of RCA CTO
干预措施: CTO coronary angioplasty (Procedure)
Stress-MRI + Chronic total occlusion PCI
Pre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Coronary angioplasty with stenting of RCA CTO
干预措施: Stress-MRI (Procedure)
Stress-MRI + Optimal medicamentous treatment
Pre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Optimal medicamentous treatment
干预措施: Optimal medicamentous treatment (Drug)
Stress-MRI + Optimal medicamentous treatment
Pre- and postoperative stress-MRI with evaluation of myocardium perfusion defects + Optimal medicamentous treatment
干预措施: Stress-MRI (Procedure)
结局指标
主要结局
Stress-MRI evaluation
时间窗: Within 2 and 12 month after hospitalization
High risk of myocardium ischemia according to stress-MRI data (perfusion defect in 2 or more segments in the area of interest)
次要结局
- Major adverse cardiac and cerebrovascular events (MACCE)(During 1 year after first stress-MRI assessment)
- Stress-MRI evaluation (2)(Within 2 and 12 month after hospitalization)
- Clinical assessment(Within 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 moths after hospitalization)