Myocardial Injury, Non-cardiac Surgery, Remote Ischemic Preconditioning
Conditions
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.
Interventions
PROCEDURERemote ischemic preconditioning
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.
PROCEDURESham-remote ischemic preconditioning
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.
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial injury after non-cardiac surgery (MINS) | Within the first three days after surgery | Number of participants with MINS, diagnosed according to the criteria established by the American Heart Association in 2021 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants with the concentration of hs-cTnT reaching/above the prognostically important thresholds | Within the first three days after surgery | Number of participants with the concentration of hs-cTnT reaching/above the prognostically important thresholds |
| Peak concentration of hs-cTnT within the initial 3 days after surgery | Within the first three days after surgery | Peak concentration of high-sensitivity cTnT |
| Total hs-cTnT release within the initial 3 days after surgery (area under the curve) | Within the first three days after surgery | Total hs-cTnT release |
| Length of stay in the intensive care unit | expected 2 days after surgery | Length of intensive care unit stay |
| Length of postoperative stay | expected 6 days after surgery | Length of hospital stay after surgery |
| Myocardial infarction | Within 30 days, 6 months, 1 year and 2 years of surgery | Number of participants with myocardial infarction |
| Major adverse cardiovascular events | Within 30 days, 6 months, 1 year and 2 years of surgery | Cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke |
| Cardiac-related death | Within 30 days, 6 months, 1 year and 2 years of surgery | Death related by cardiac reason |
| All deaths | Within 30 days, 6 months, 1 year and 2 years of surgery | All-cause death after surgery |
| Major postoperative morbidity | Within 30 days after surgery | Major postoperative morbidity |
| Adverse events | Within 30 days after surgery | Adverse events |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORYang Zhao, MD
Sixth SunYetSen
Outcome results
None listed