The Effect of Remote Ischemic Preconditioning on Myocardial Injury After Noncardiac Surgery in Patients at a High Risk of Cardiac Events
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 766
- 试验地点
- 1
- 主要终点
- Myocardial injury after non-cardiac surgery (MINS)
研究概览
简要总结
This is a multicentre, parallel-group, randomised, sham-controlled, observer blinded trial, assessing the efficacy of remote ischemic preconditioning on preventing myocardial injury after noncardiac surgery.
详细描述
This is a multicentre, randomised, sham-controlled, observer blinded trial. Patients at high clinical risk for cardiovascular events and scheduled to undergo major abdominal surgery will be enrolled. A total of 766 patients are randomised (1:1 ratio) to receive RIPC or no RIPC (control) before anaesthesia induction. RIPC will comprise four alternating cycles of cuff inflation for 5 min to 200 mm Hg and deflation for 5 min. In controls, the identical looking cuff will be placed around the arm but not actually inflated for 40 minutes. The primary outcome was myocardial injury after surgery within three days of surgery. The secondary outcomes were peak plasma hs-cTnT and total hs-cTnT release during the first three days after surgery, hs-cTnT above the prognostically important thresholds, length of hospital stay after surgery, and length of stay in the intensive care unit, myocardial infarction, major adverse cardiovascular events, cardiac-related death and all cause death within 30 days, 6 months, 1 year and 2 years after surgery, postoperative morbidity and adverse events within 30 days after surgery. Besides, blood samples were stored for the other ancillary studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at high clinical risk for cardiovascular events;
- •Patients scheduled to undergo major abdominal surgery.
排除标准
- •Immediate or urgent surgery or surgery where there is insufficient time to perform RIPC.
- •Abdominal vascular surgery, such as surgery for abdominal aortic aneurysm
- •Experience of conditions precluding the use of RIPC in both arms
- •Patients who are being treated with drugs, such as sulphonamide or nicorandil
- •With contraindications for anaesthetic regimes required in this trial.
研究组 & 干预措施
Remote ischemic preconditioning
Transient ischemic ischemia consisting of 5-minute ischemia followed by 5-minute perfusion will occur on the upper arm
干预措施: Remote ischemic preconditioning (Procedure)
Sham-remote ischemic preconditioning
Transient ischemic ischemia will not actually occur on the upper arm
干预措施: Sham-remote ischemic preconditioning (Procedure)
结局指标
主要结局
Myocardial injury after non-cardiac surgery (MINS)
时间窗: Within the first three days after surgery
Number of participants with MINS, diagnosed according to the criteria established by the American Heart Association in 2021
次要结局
- Length of postoperative stay(expected 6 days after surgery)
- Cardiac-related death(Within 30 days, 6 months, 1 year and 2 years of surgery)
- Myocardial infarction(Within 30 days, 6 months, 1 year and 2 years of surgery)
- Peak concentration of hs-cTnT within the initial 3 days after surgery(Within the first three days after surgery)
- Length of stay in the intensive care unit(expected 2 days after surgery)
- Participants with the concentration of hs-cTnT reaching/above the prognostically important thresholds(Within the first three days after surgery)
- Major adverse cardiovascular events(Within 30 days, 6 months, 1 year and 2 years of surgery)
- All deaths(Within 30 days, 6 months, 1 year and 2 years of surgery)
- Major postoperative morbidity(Within 30 days after surgery)
- Total hs-cTnT release within the initial 3 days after surgery (area under the curve)(Within the first three days after surgery)
- Adverse events(Within 30 days after surgery)
研究者
Yang Zhao
Principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University