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

Sun Yat-sen University

Status: Active, not recruiting

Conditions: Non-cardiac Surgery; Remote Ischemic Preconditioning; Myocardial Injury

Treatments: Procedure: Remote ischemic preconditioning; Procedure: Sham-remote ischemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT05733208

E2022236

Details and patient eligibility

About

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.

Full 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.

Enrollment: 766 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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766 participants in 2 patient groups

Remote ischemic preconditioning

Experimental group

Description:

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

Treatment:

Procedure: Remote ischemic preconditioning

Sham-remote ischemic preconditioning

Sham Comparator group

Description:

Transient ischemic ischemia will not actually occur on the upper arm

Treatment:

Procedure: Sham-remote ischemic preconditioning