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. Besides, blood samples were stored for the other ancillary studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
766
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.
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Myocardial injury after non-cardiac surgery (MINS)
Number of participants with MINS, diagnosed according to the criteria established by the American Heart Association in 2021
Time frame: Within the first three days after surgery
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
Time frame: Within the first three days after surgery
Peak concentration of hs-cTnT within the initial 3 days after surgery
Peak concentration of high-sensitivity cTnT
Time frame: Within the first three days after surgery
Total hs-cTnT release within the initial 3 days after surgery (area under the curve)
Total hs-cTnT release
Time frame: Within the first three days after surgery
Length of stay in the intensive care unit
Length of intensive care unit stay
Time frame: expected 2 days after surgery
Length of postoperative stay
Length of hospital stay after surgery
Time frame: expected 6 days after surgery
Myocardial infarction
Number of participants with myocardial infarction
Time frame: Within 30 days, 6 months, 1 year and 2 years of surgery
Major adverse cardiovascular events
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Cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke
Time frame: Within 30 days, 6 months, 1 year and 2 years of surgery
Cardiac-related death
Death related by cardiac reason
Time frame: Within 30 days, 6 months, 1 year and 2 years of surgery
All deaths
All-cause death after surgery
Time frame: Within 30 days, 6 months, 1 year and 2 years of surgery
Major postoperative morbidity
Major postoperative morbidity
Time frame: Within 30 days after surgery
Adverse events
Adverse events
Time frame: Within 30 days after surgery