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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. Besides, blood samples were stored for the other ancillary studies.
Age
45 - No limit years
Sex
ALL
Healthy Volunteers
No
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Start Date
May 6, 2023
Primary Completion Date
July 2, 2024
Completion Date
December 31, 2026
Last Updated
December 9, 2024
766
ESTIMATED participants
Remote ischemic preconditioning
PROCEDURE
Sham-remote ischemic preconditioning
PROCEDURE
Lead Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
NCT05198791
NCT06474754
Data Source & Attribution
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