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

NCT05733208 | Active Not Recruiting DMC

• 1 other identifier: E2022236
• Study Type: interventional
• Target: 766
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Injury; Non-cardiac Surgery; Remote Ischemic Preconditioning

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• 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

  Within the first three days after surgery

• Total hs-cTnT release within the initial 3 days after surgery (area under the curve)

  Within the first three days after surgery

• Length of stay in the intensive care unit

  expected 2 days after surgery

• Length of postoperative stay

  expected 6 days after surgery

Other Outcomes (2)

• Acute kidney injury

  Within 30 days after surgery

• Postoperative pulmonary complications

  Within 30 days after surgery

Study Arms (2)

Remote ischemic preconditioning

EXPERIMENTAL

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

Procedure: Remote ischemic preconditioning

Sham-remote ischemic preconditioning

SHAM COMPARATOR

Transient ischemic ischemia will not actually occur on the upper arm

Procedure: Sham-remote ischemic preconditioning

Interventions

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.

Remote ischemic preconditioning

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.

Sham-remote ischemic preconditioning

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at high clinical risk for cardiovascular events;
• Patients scheduled to undergo major abdominal surgery.

You may not qualify if:

• Immediate or urgent surgery or surgery where there is insufficient time to perform RIPC.
• Abdominal vascular surgery, such as surgery for abdominal aortic aneurysm
• Experience of conditions precluding the use of RIPC in both arms
• Patients who are being treated with drugs, such as sulphonamide or nicorandil
• With contraindications for anaesthetic regimes required in this trial.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

Related Publications (19)

• 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.

  PMID: 26630144 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.

  PMID: 28444280 BACKGROUND

• Smilowitz NR, Berger JS. Perioperative Management to Reduce Cardiovascular Events. Circulation. 2016 Mar 15;133(11):1125-30. doi: 10.1161/CIRCULATIONAHA.115.017787. No abstract available.

  PMID: 26976917 BACKGROUND

• Smilowitz NR, Redel-Traub G, Hausvater A, Armanious A, Nicholson J, Puelacher C, Berger JS. Myocardial Injury After Noncardiac Surgery: A Systematic Review and Meta-Analysis. Cardiol Rev. 2019 Nov/Dec;27(6):267-273. doi: 10.1097/CRD.0000000000000254.

  PMID: 30985328 BACKGROUND

• Puelacher C, Bollen Pinto B, Mills NL, Duceppe E, Popova E, Duma A, Nagele P, Omland T, Hammerer-Lercher A, Lurati Buse G. Expert consensus on peri-operative myocardial injury screening in noncardiac surgery: A literature review. Eur J Anaesthesiol. 2021 Jun 1;38(6):600-608. doi: 10.1097/EJA.0000000000001486.

  PMID: 33653981 BACKGROUND

• Ruetzler K, Smilowitz NR, Berger JS, Devereaux PJ, Maron BA, Newby LK, de Jesus Perez V, Sessler DI, Wijeysundera DN. Diagnosis and Management of Patients With Myocardial Injury After Noncardiac Surgery: A Scientific Statement From the American Heart Association. Circulation. 2021 Nov 9;144(19):e287-e305. doi: 10.1161/CIR.0000000000001024. Epub 2021 Oct 4.

  PMID: 34601955 BACKGROUND

• Verbree-Willemsen L, Grobben RB, van Waes JA, Peelen LM, Nathoe HM, van Klei WA, Grobbee DE. Causes and prevention of postoperative myocardial injury. Eur J Prev Cardiol. 2019 Jan;26(1):59-67. doi: 10.1177/2047487318798925. Epub 2018 Sep 12.

  PMID: 30207484 BACKGROUND

• Loukogeorgakis SP, Williams R, Panagiotidou AT, Kolvekar SK, Donald A, Cole TJ, Yellon DM, Deanfield JE, MacAllister RJ. Transient limb ischemia induces remote preconditioning and remote postconditioning in humans by a K(ATP)-channel dependent mechanism. Circulation. 2007 Sep 18;116(12):1386-95. doi: 10.1161/CIRCULATIONAHA.106.653782. Epub 2007 Aug 27.

  PMID: 17724264 BACKGROUND

• Botker HE, Kharbanda R, Schmidt MR, Bottcher M, Kaltoft AK, Terkelsen CJ, Munk K, Andersen NH, Hansen TM, Trautner S, Lassen JF, Christiansen EH, Krusell LR, Kristensen SD, Thuesen L, Nielsen SS, Rehling M, Sorensen HT, Redington AN, Nielsen TT. Remote ischaemic conditioning before hospital admission, as a complement to angioplasty, and effect on myocardial salvage in patients with acute myocardial infarction: a randomised trial. Lancet. 2010 Feb 27;375(9716):727-34. doi: 10.1016/S0140-6736(09)62001-8.

  PMID: 20189026 BACKGROUND

• Thielmann M, Kottenberg E, Kleinbongard P, Wendt D, Gedik N, Pasa S, Price V, Tsagakis K, Neuhauser M, Peters J, Jakob H, Heusch G. Cardioprotective and prognostic effects of remote ischaemic preconditioning in patients undergoing coronary artery bypass surgery: a single-centre randomised, double-blind, controlled trial. Lancet. 2013 Aug 17;382(9892):597-604. doi: 10.1016/S0140-6736(13)61450-6.

  PMID: 23953384 BACKGROUND

• Lau JK, Pennings GJ, Reddel CJ, Campbell H, Liang HPH, Traini M, Gardiner EE, Yong AS, Chen VM, Kritharides L. Remote ischemic preconditioning inhibits platelet alphaIIb beta3 activation in coronary artery disease patients receiving dual antiplatelet therapy: A randomized trial. J Thromb Haemost. 2020 May;18(5):1221-1232. doi: 10.1111/jth.14763. Epub 2020 Mar 13.

  PMID: 32056358 BACKGROUND

• Reddel CJ, Pennings GJ, Lau JK, Chen VM, Kritharides L. Circulating platelet-derived extracellular vesicles are decreased after remote ischemic preconditioning in patients with coronary disease: A randomized controlled trial. J Thromb Haemost. 2021 Oct;19(10):2605-2611. doi: 10.1111/jth.15441. Epub 2021 Aug 10.

  PMID: 34196106 BACKGROUND

• Crimi G, Pica S, Raineri C, Bramucci E, De Ferrari GM, Klersy C, Ferlini M, Marinoni B, Repetto A, Romeo M, Rosti V, Massa M, Raisaro A, Leonardi S, Rubartelli P, Oltrona Visconti L, Ferrario M. Remote ischemic post-conditioning of the lower limb during primary percutaneous coronary intervention safely reduces enzymatic infarct size in anterior myocardial infarction: a randomized controlled trial. JACC Cardiovasc Interv. 2013 Oct;6(10):1055-63. doi: 10.1016/j.jcin.2013.05.011.

  PMID: 24156966 BACKGROUND

• White SK, Frohlich GM, Sado DM, Maestrini V, Fontana M, Treibel TA, Tehrani S, Flett AS, Meier P, Ariti C, Davies JR, Moon JC, Yellon DM, Hausenloy DJ. Remote ischemic conditioning reduces myocardial infarct size and edema in patients with ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt B):178-188. doi: 10.1016/j.jcin.2014.05.015. Epub 2014 Sep 17.

  PMID: 25240548 BACKGROUND

• Gaspar A, Lourenco AP, Pereira MA, Azevedo P, Roncon-Albuquerque R Jr, Marques J, Leite-Moreira AF. Randomized controlled trial of remote ischaemic conditioning in ST-elevation myocardial infarction as adjuvant to primary angioplasty (RIC-STEMI). Basic Res Cardiol. 2018 Mar 7;113(3):14. doi: 10.1007/s00395-018-0672-3.

  PMID: 29516192 BACKGROUND

• Xie J, Zhang X, Xu J, Zhang Z, Klingensmith NJ, Liu S, Pan C, Yang Y, Qiu H. Effect of Remote Ischemic Preconditioning on Outcomes in Adult Cardiac Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Studies. Anesth Analg. 2018 Jul;127(1):30-38. doi: 10.1213/ANE.0000000000002674.

  PMID: 29210794 BACKGROUND

• Jiang Q, Xiang B, Wang H, Huang K, Kong H, Hu S. Remote ischaemic preconditioning ameliorates sinus rhythm restoration rate through Cox maze radiofrequency procedure associated with inflammation reaction reduction. Basic Res Cardiol. 2019 Mar 5;114(3):14. doi: 10.1007/s00395-019-0723-4.

  PMID: 30838448 BACKGROUND

• Kosiuk J, Langenhan K, Stegmann C, Uhe T, Dagres N, Dinov B, Kircher S, Richter S, Sommer P, Bertagnolli L, Bollmann A, Hindricks G. Effect of remote ischemic preconditioning on electrophysiological parameters in nonvalvular paroxysmal atrial fibrillation: The RIPPAF Randomized Clinical Trial. Heart Rhythm. 2020 Jan;17(1):3-9. doi: 10.1016/j.hrthm.2019.07.026. Epub 2019 Jul 26.

  PMID: 31356986 BACKGROUND

• Wang F, Liang CJ, Shi JK, Huang QS, Nassirou BM, Wang X, Jin SQ, Zhao Y. Effects of remote ischaemic preconditioning on myocardial injury after major abdominal surgery in patients at high risk for cardiovascular adverse events in China (RIPC-MAS): protocol for a randomised, sham-controlled, observer-blinded trial. BMJ Open. 2023 Jun 23;13(6):e073038. doi: 10.1136/bmjopen-2023-073038.

  PMID: 37355267 DERIVED

Study Officials

• Yang Zhao, MD

  Sixth SunYetSen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 17, 2023
• Study Start: May 6, 2023
• Primary Completion: July 2, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: from 6 months to 36 months after publication
• Access Criteria: 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.

Locations

CN (1)