The Effect of Remote Ischemic Preconditioning on Myocardial Injury After Noncardiac Surgery
- Conditions
- Myocardial InjuryNon-cardiac SurgeryRemote Ischemic Preconditioning
- Interventions
- Procedure: Sham-remote ischemic preconditioningProcedure: Remote ischemic preconditioning
- Registration Number
- NCT05733208
- Lead Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 766
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham-remote ischemic preconditioning Sham-remote ischemic preconditioning Transient ischemic ischemia will not actually occur on the upper arm Remote ischemic preconditioning Remote ischemic preconditioning Transient ischemic ischemia consisting of 5-minute ischemia followed by 5-minute perfusion will occur on the upper arm
- Primary Outcome Measures
Name Time Method Myocardial injury after non-cardiac surgery (MINS) 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
- Secondary Outcome Measures
Name Time Method Length of postoperative stay expected 6 days after surgery Length of hospital stay after surgery
Major postoperative morbidity Within 30 days after surgery Major postoperative morbidity
Cardiac-related death Within 30 days, 6 months, 1 year and 2 years of surgery Death related by cardiac reason
Myocardial infarction Within 30 days, 6 months, 1 year and 2 years of surgery Number of participants with myocardial infarction
Peak concentration of hs-cTnT within the initial 3 days after surgery Within the first three days after surgery Peak concentration of high-sensitivity cTnT
Length of stay in the intensive care unit expected 2 days after surgery Length of intensive care unit stay
Participants with the concentration of hs-cTnT reaching/above the prognostically important thresholds Within the first three days after surgery Number of participants with the concentration of hs-cTnT reaching/above the prognostically important thresholds
Major adverse cardiovascular events Within 30 days, 6 months, 1 year and 2 years of surgery Cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke
All deaths Within 30 days, 6 months, 1 year and 2 years of surgery All-cause death after surgery
Total hs-cTnT release within the initial 3 days after surgery (area under the curve) Within the first three days after surgery Total hs-cTnT release
Adverse events Within 30 days after surgery Adverse events
Trial Locations
- Locations (1)
The Sixth Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China