Prospective Clinical Study for Evaluation of Perioperative Myocardial Injury Using High-Sensitivity Troponin and Cardiac MRI in Patients Undergoing Coronary Artery Bypass Grafting (CABG)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence of Perioperative Myocardial Injury (PMI)
研究概览
简要总结
Perioperative myocardial injury (PMI) following coronary artery bypass grafting (CABG) is associated with postoperative morbidity, mortality, and long-term outcomes. High-sensitivity troponin assays and cardiac MRI offer reliable diagnostic tools for PMI, but evidence regarding optimal diagnostic thresholds and perioperative imaging strategy is limited. This prospective clinical study aims to determine the incidence of perioperative myocardial injury using multimodal assessments including high-sensitivity troponin, electrocardiogram, echocardiography, cardiac MRI, and perioperative cardiovascular events.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 years
- •Undergoing CABG for unstable angina
- •Able to provide written informed consent
- •No major cardiovascular event in the prior 6 months
排除标准
- •Significant hepatic, renal, or other major organ dysfunction
- •Pregnancy or breastfeeding
- •Withdrawal during the study
- •Contraindication to cardiac MRI (metal implants, claustrophobia, etc.)
研究组 & 干预措施
CABG Patients
A prospective cohort of adult patients undergoing elective or urgent coronary artery bypass grafting. Participants will undergo perioperative evaluation including hs-troponin testing, ECG, echocardiography, and cardiac MRI to assess perioperative myocardial injury.
干预措施: High-Sensitivity Troponin (Diagnostic Test)
CABG Patients
A prospective cohort of adult patients undergoing elective or urgent coronary artery bypass grafting. Participants will undergo perioperative evaluation including hs-troponin testing, ECG, echocardiography, and cardiac MRI to assess perioperative myocardial injury.
干预措施: Cardiac MRI (Diagnostic Test)
结局指标
主要结局
Incidence of Perioperative Myocardial Injury (PMI)
时间窗: Within 48 hours post-CABG
Perioperative myocardial injury defined by elevation of high-sensitivity troponin above the 99th percentile upper reference limit together with new myocardial injury detected by cardiac MRI or supportive ECG/echocardiographic changes. PMI is assessed using laboratory testing and imaging performed preoperatively, within 48 hours post-CABG, and at discharge.
次要结局
未报告次要终点
研究者
Kexiang Liu, MD
Principal Investigator
Second Hospital of Jilin University