Clinical trial NCT05733208: The Effect of Remote Ischemic Preconditioning on Myocardial Injury After Noncardiac Surgery
Official title: The Effect of Remote Ischemic Preconditioning on Myocardial Injury After Noncardiac Surgery in Patients at a High Risk of Cardiac Events
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myocardial Injury
Non-cardiac Surgery
Remote Ischemic Preconditioning
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 766
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Myocardial injury after non-cardiac surgery (MINS)
timeFrame: Within the first three days after surgery
Secondary outcomes:
measure: Participants with the concentration of hs-cTnT reaching/above the prognostically important thresholds
timeFrame: Within the first three days after surgery
measure: Peak concentration of hs-cTnT within the initial 3 days after surgery
timeFrame: Within the first three days after surgery
measure: Total hs-cTnT release within the initial 3 days after surgery (area under the curve)
timeFrame: Within the first three days after surgery
measure: Length of stay in the intensive care unit
timeFrame: expected 2 days after surgery
measure: Length of postoperative stay
timeFrame: expected 6 days after surgery
measure: Myocardial infarction
timeFrame: Within 30 days, 6 months, 1 year and 2 years of surgery
measure: Major adverse cardiovascular events
timeFrame: Within 30 days, 6 months, 1 year and 2 years of surgery
measure: Cardiac-related death
timeFrame: Within 30 days, 6 months, 1 year and 2 years of surgery
measure: All deaths
timeFrame: Within 30 days, 6 months, 1 year and 2 years of surgery
measure: Major postoperative morbidity
timeFrame: Within 30 days after surgery
measure: Adverse events
timeFrame: Within 30 days after surgery
Other outcomes:
measure: Acute kidney injury
timeFrame: Within 30 days after surgery
measure: Postoperative pulmonary complications
timeFrame: Within 30 days after surgery
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sixth SunYetSen
name: Yang Zhao, MD
role: PRINCIPAL_INVESTIGATOR
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