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Myocardial InjuryNCT05733208

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

A study testing Remote ischemic preconditioning in people with Myocardial Injury and Non-cardiac Surgery, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 years and older
What is being tested?
Remote ischemic preconditioning
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
766 participants
Where
1 siteChina
Study dates
6 May 2023to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • The Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510655

Other trials in China

About this study

Official title: The Effect of Remote Ischemic Preconditioning on Myocardial Injury After Noncardiac Surgery in Patients at a High Risk of Cardiac Events

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.

Read the 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.

Being tested
Remote ischemic preconditioning, Sham-remote ischemic preconditioning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote ischemic preconditioningProcedure or surgery

    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.

  • Sham-remote ischemic preconditioningProcedure or surgery

    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.

Study groups in NCT05733208
Study groupRoleWhat they receive
Remote ischemic preconditioningExperimentalTransient ischemic ischemia consisting of 5-minute ischemia followed by 5-minute perfusion will occur on the upper arm
Receives: Procedure: Remote ischemic preconditioning
Sham-remote ischemic preconditioningSham comparatorTransient ischemic ischemia will not actually occur on the upper arm
Receives: Procedure: Sham-remote ischemic preconditioning

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Within the first three days after surgery

Secondary outcomes (11)
  1. 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

    Measured: Within the first three days after surgery

  2. Peak concentration of hs-cTnT within the initial 3 days after surgery

    Peak concentration of high-sensitivity cTnT

    Measured: Within the first three days after surgery

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

    Total hs-cTnT release

    Measured: Within the first three days after surgery

  4. Length of stay in the intensive care unit

    Length of intensive care unit stay

    Measured: expected 2 days after surgery

  5. Length of postoperative stay

    Length of hospital stay after surgery

    Measured: expected 6 days after surgery

  6. Myocardial infarction

    Number of participants with myocardial infarction

    Measured: Within 30 days, 6 months, 1 year and 2 years of surgery

  7. Major adverse cardiovascular events

    Cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke

    Measured: Within 30 days, 6 months, 1 year and 2 years of surgery

  8. Cardiac-related death

    Death related by cardiac reason

    Measured: Within 30 days, 6 months, 1 year and 2 years of surgery

  9. All deaths

    All-cause death after surgery

    Measured: Within 30 days, 6 months, 1 year and 2 years of surgery

  10. Major postoperative morbidity

    Major postoperative morbidity

    Measured: Within 30 days after surgery

  11. Adverse events

    Adverse events

    Measured: Within 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2023
  2. Study start6 May 2023
  3. Primary completion2 Jul 2024
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
766 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05733208
Sponsor's protocol ID
E2022236
Status last verified
Apr 2026
First submitted
6 Feb 2023
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 26630144
  • 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.

    PubMed 28444280
  • 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.

    PubMed 26976917
  • 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.

    PubMed 30985328
  • 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.

    PubMed 33653981
  • 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.

    PubMed 34601955
  • 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.

    PubMed 30207484
  • 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.

    PubMed 17724264
  • 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.

    PubMed 20189026
  • 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.

    PubMed 23953384
  • 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.

    PubMed 32056358
  • 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.

    PubMed 34196106
  • 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.

    PubMed 24156966
  • 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.

    PubMed 25240548
  • 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.

    PubMed 29516192

Questions about this trial

What is this clinical trial studying?

A study testing Remote ischemic preconditioning in people with Myocardial Injury and Non-cardiac Surgery, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial injury after non-cardiac surgery (MINS) (time frame: Within the first three days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05733208, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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