The Success of Opening Concurrent Chronic Total Occlusion leSion to Improve Cardiac Function Trial in Patients With Multi-vessel Disease (SOS-moral): Study Protocol of a Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Changes of left ventricular ejection fraction (LVEF)
研究概览
简要总结
The purpose of this study is to investigate the effect of percutaneous coronary intervention (PCI) on cardiac function in multi-vessel disease patients with concurrent chronic total occlusion (CTO) lesion.
详细描述
Recruited CTO patients will be devided into two groups: those undergoing PCI of only the non-CTO artery (non-CTO PCI group), and those undergoing PCI of the non-CTO artery concurrently with the CTO artery (CTO-PCI group). The primary outcome assessed will be the change in cardiac function evaluated via CMR at a 12-month of follow-up appointment, which will be compared to a baseline measurement. Secondary outcomes include occurrence of major cardiac events, CMR-assessed myocardial viability in the CTO-supplied territory, and quality of life assessed by Seattle angina questionnaire, Patient Health Questionnaire 9 and Generalized Anxiety Disorder Scale-7 after 12-month follow-up.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Complete revascularization group
Complete Revascularization of CTO and non-CTO lesions
干预措施: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor (Drug)
Complete revascularization group
Complete Revascularization of CTO and non-CTO lesions
干预措施: coronary wires. stents or coronary balloons (Device)
Non-CTO revascularization group
Non-CTO vessel revascularization
干预措施: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor (Drug)
Non-CTO revascularization group
Non-CTO vessel revascularization
干预措施: coronary wires. stents or coronary balloons (Device)
结局指标
主要结局
Changes of left ventricular ejection fraction (LVEF)
时间窗: 12 months
Changes of LVEF, LVEDV, and LVESV assessed with the use of cardiac MRI.
次要结局
- Myocardial viability(12 months post-PCI)
- Quality of life changes(1, 6, and 12-month follow-up)
- Total cost of medical care(from the day of enrollment (first hospitalization) to the last follow-up (rehospitalization))
- Major adverse cardiac events(1, 6, and 12 months post-PCI)
- Contrast used(during the procedure)
研究者
Xiantao Song, MD
Professor
Beijing Anzhen Hospital