Coronary Computed Tomography Angiography-Based Versus Coronary Angiography-Based Coronary Artery Bypass Grafting: A Multicenter Pragmatic Non-Inferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 826
- 试验地点
- 1
- 主要终点
- 1-year incidence of 5-Point Major Adverse Cardiovascular Events (5P-MACE)
研究概览
简要总结
The goal of this clinical trial is to find out if using a non-invasive heart scan (called coronary computed tomography angiography, or CCTA) to plan coronary artery bypass grafting (CABG) works as well as the standard invasive approach (called coronary angiography, or CAG) for people with blocked heart arteries.
The main questions it aims to answer are:
Do people who have surgery planned with the non-invasive heart scan have similar health outcomes at 1 year as those who have surgery planned with the standard invasive approach? How does the non-invasive approach compare in terms of heart attacks, strokes, unplanned repeat procedures, and longer hospital stays? Researchers will compare two groups of participants. One group will have their surgery planned using only the CCTA . The other group will have their surgery planned using only the CAG. Both groups will undergo the CABG per local protocol.
Participants will:
Be randomly assigned (like flipping a coin) to one of the two planning approaches Undergo CABG as scheduled Return for follow-up visits at sugery days, 7 days, 1 month, 6 months, and 1 year after surgery Have a follow-up CCTA scan at 7 days and 1 year to check if the new bypass grafts are working well
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Referred to CABG treatment
排除标准
- •Under the age of 18 years
- •Unable to provide informed consent
- •Emergency CABG
- •Redo-CABG
- •Prior PCI with coronary stent implantation
- •Cardiogenic shock
- •Unable to undergo CAG or CCTA examination or deemed unsuitable by the investigator, such as:
- •Known allergy to iodinated contrast media; Active hyperthyroidism or uncontrolled thyroid disease; Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m²; Atrial fibrillation with rapid ventricular response or severe arrhythmias not amenable to rate control;
- •Pregnancy, lactation, or childbearing potential without effective contraception in female participants
- •Concurrent participation in another interventional trial
研究组 & 干预措施
CCTA-Based CABG
干预措施: CCTA-based CABG (Procedure)
CAG-Based CABG
干预措施: CAG-based CABG (Procedure)
结局指标
主要结局
1-year incidence of 5-Point Major Adverse Cardiovascular Events (5P-MACE)
时间窗: Within 1 year post-CABG
The 5P-MACE was defined as a composite of all-cause death, myocardial infarction, stroke, unplanned revascularization, and CABG-related or cardiovascular-related prolonged postoperative length of stay (PLOS) or rehospitalization.
次要结局
- 1-year incidence of all-cause death(Within 1 year post-CABG)
- 1-year incidence of MI(Within 1 year post-CABG)
- 1-year incidence of stroke(Within 1 year post-CABG)
- 1-year incidence of unplanned revascularization(Within 1 year post-CABG)
- 1-year incidence of CABG-related or CV-related prolonged PLOS or rehospitalization.(Within 1 year post-CABG)
- 7-day graft failure rate(At 7 day post-CABG)
- 1-year graft failure rate(At 1 year post-CABG)
- Other serious adverse events (SAE)(Within 1 year post-CABG)
- 1-year incidence of CV death(within 1 year post-CABG)
- 30-day incidence of the operative mortality and morbidity(Within 30 days post-CABG)
研究者
Zhu yunpeng
Professor and Director of Clinical Research, Department of Cardiovascular Surgery
Ruijin Hospital