The Effect of Remote Ischemic Preconditioning on Myocardial Injury After Noncardiac Surgery in Patients at a High Risk of Cardiac Events
Overview
- Phase
- Not Applicable
- Intervention
- Remote ischemic preconditioning
- Conditions
- Myocardial Injury
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Enrollment
- 766
- Locations
- 2
- Primary Endpoint
- Myocardial injury after non-cardiac surgery (MINS)
- Status
- Active, not recruiting
- Last Updated
- 10 days ago
Overview
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.
Investigators
Yang Zhao
Principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •Patients at high clinical risk for cardiovascular events;
- •Patients scheduled to undergo major abdominal surgery.
Exclusion Criteria
- •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.
Arms & Interventions
Remote ischemic preconditioning
Transient ischemic ischemia consisting of 5-minute ischemia followed by 5-minute perfusion will occur on the upper arm
Intervention: Remote ischemic preconditioning
Sham-remote ischemic preconditioning
Transient ischemic ischemia will not actually occur on the upper arm
Intervention: Sham-remote ischemic preconditioning
Outcomes
Primary Outcomes
Myocardial injury after non-cardiac surgery (MINS)
Time Frame: 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 Outcomes
- 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)