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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote ischemic preconditioning | Experimental | Transient ischemic ischemia consisting of 5-minute ischemia followed by 5-minute perfusion will occur on the upper arm |
|
| Sham-remote ischemic preconditioning | Sham Comparator | Transient ischemic ischemia will not actually occur on the upper arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic preconditioning | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial injury after non-cardiac surgery (MINS) | Number of participants with MINS, diagnosed according to the criteria established by the American Heart Association in 2021 | Within the first three days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Participants with the concentration of hs-cTnT reaching/above the prognostically important thresholds | Number of participants with the concentration of hs-cTnT reaching/above the prognostically important thresholds | Within the first three days after surgery |
| Peak concentration of hs-cTnT within the initial 3 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Acute kidney injury | Acute kidney injury | Within 30 days after surgery |
| Postoperative pulmonary complications | Postoperative pulmonary complications |
Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Yang Zhao, MD | Sixth SunYetSen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sixth Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510655 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26630144 | Background | Devereaux PJ, Sessler DI. Cardiac Complications in Patients Undergoing Major Noncardiac Surgery. N Engl J Med. 2015 Dec 3;373(23):2258-69. doi: 10.1056/NEJMra1502824. No abstract available. | |
| 28444280 | Background | Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS, Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017 Apr 25;317(16):1642-1651. doi: 10.1001/jama.2017.4360. |
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The data shown in the tables or figures in the published paper will be shared with other researchers on reasonable requests. Reasonable requests for data sharing should be made to the corresponding author and will be handled in line with the data access and sharing policy of the Human Genetic Resource Administration of China.
from 6 months to 36 months after publication
Reasonable requests for data sharing should be made to the corresponding author and will be handled in line with the data access and sharing policy of the Human Genetic Resource Administration of China.
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| Sham-remote ischemic preconditioning | Procedure | 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. |
|
Peak concentration of high-sensitivity cTnT |
| Within the first three days after surgery |
| Total hs-cTnT release within the initial 3 days after surgery (area under the curve) | Total hs-cTnT release | Within the first three days after surgery |
| Length of stay in the intensive care unit | Length of intensive care unit stay | expected 2 days after surgery |
| Length of postoperative stay | Length of hospital stay after surgery | expected 6 days after surgery |
| Myocardial infarction | Number of participants with myocardial infarction | Within 30 days, 6 months, 1 year and 2 years of surgery |
| Major adverse cardiovascular events | Cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke | Within 30 days, 6 months, 1 year and 2 years of surgery |
| Cardiac-related death | Death related by cardiac reason | Within 30 days, 6 months, 1 year and 2 years of surgery |
| All deaths | All-cause death after surgery | Within 30 days, 6 months, 1 year and 2 years of surgery |
| Major postoperative morbidity | Major postoperative morbidity | Within 30 days after surgery |
| Adverse events | Adverse events | Within 30 days after surgery |
| Within 30 days after surgery |
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| 42020240 | Derived | Zheng Z, Wang F, Wang X, Shi J, Zhang S, Zheng Y, Jiang B, Huang Y, Zhao Y, Lin C, Zheng J, Yu C, Liu C, Luo T, Li S, Huang Q, Zheng J, Wang K, Li Z, Liu D, Zhao Y. Effect of two-session remote ischaemic preconditioning on myocardial injury after noncardiac surgery in patients undergoing abdominal surgery: a randomised clinical trial. Br J Anaesth. 2026 Jul;137(1):55-65. doi: 10.1016/j.bja.2026.03.029. Epub 2026 Apr 21. |
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