The Effect of Remote Ischemic Preconditioning on Myocardial Injury After Noncardiac Surgery

The Effect of Remote Ischemic Preconditioning on Myocardial Injury After Noncardiac Surgery in Patients at a High Risk of Cardiac Events

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.

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.

Transient ischemic ischemia consisting of 5-minute ischemia followed by 5-minute perfusion will occur on the upper arm

Remote ischemic preconditioning will consist of four cycles of 5-minute inflation of an blood pressure cuff on the upper arm to 200 mmHg followed by 5-minute deflation. RIPC will be performed twice, one at approximately 24 hours before anaesthesia and the other at approximately 1 hour before anaesthesia.

The identical looking cuff will be placed around the upper arm but not actually inflated for 40 minutes. The control device's components and external appearance are identical to that of the RIPC. However, as compared to the RIPC, the blood pressure cuff's line of inflation is disconnected such that the cuff cannot be inflated. Control treatment will be performed twice, one at approximately 24 hours before anaesthesia and the other at approximately 1 hour before anaesthesia.

Number of participants with MINS, diagnosed according to the criteria established by the American Heart Association in 2021

Participants with the concentration of hs-cTnT reaching/above the prognostically important thresholds

Number of participants with the concentration of hs-cTnT reaching/above the prognostically important thresholds

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.

The data shown in the tables or figures in the published paper will be shared with other researchers on reasonable requests. Reasonable requests for data sharing should be made to the corresponding author and will be handled in line with the data access and sharing policy of the Human Genetic Resource Administration of China.

Reasonable requests for data sharing should be made to the corresponding author and will be handled in line with the data access and sharing policy of the Human Genetic Resource Administration of China.

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