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Active (not recruiting) Not applicable NCT05733208

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

No applicable phase (e.g. observational)
Conditions: Myocardial Injury Non-cardiac Surgery Remote Ischemic Preconditioning

Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

trial.available_in: БГ
Overview
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.
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.
Who can participate
Inclusion criteria 1. Patients at high clinical risk for cardiovascular events; 2. Patients scheduled to undergo major abdominal surgery. Exclusion criteria 1. Immediate or urgent surgery or surgery where there is insufficient time to perform RIPC. 2. Abdominal vascular surgery, such as surgery for abdominal aortic aneurysm 3. Experience of conditions precluding the use of RIPC in both arms 4. Patients who are being treated with drugs, such as sulphonamide or nicorandil 5. With contraindications for anaesthetic regimes required in this trial.
Interventions
Remote ischemic preconditioning
PROCEDURE
Sham-remote ischemic preconditioning
PROCEDURE
Locations 1
China (1)
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou , Guangdong
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
45 Years
Healthy volunteers
No
Start date
06.05.2023
Completion date
31.12.2026
Registry ID
NCT05733208
Source
clinicaltrials.gov
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