- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05733208
The Effect of Remote Ischemic Preconditioning on Myocardial Injury After Noncardiac Surgery
February 19, 2024 updated by: Yang Zhao, Sixth Affiliated Hospital, Sun Yat-sen University
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
766
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yang Zhao, MD
- Phone Number: 0086-13802435520
- Email: zhaoy47@mail.sysu.edu.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510655
- Recruiting
- The Sixth Affiliated Hospital, Sun Yat-sen University
-
Contact:
- Yang Zhao, MD
- Phone Number: 0086-13802435520
- Email: zhaoy47@mail.sysu.edu.cn
-
Contact:
- Zhinan Zheng, MD
- Phone Number: 0086-15915734893
- Email: zhengzhn5@mail.sysu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion criteria
- Patients at high clinical risk for cardiovascular events;
- Patients scheduled to undergo major abdominal surgery.
Exclusion criteria
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Remote ischemic preconditioning
Transient ischemic ischemia consisting of 5-minute ischemia followed by 5-minute perfusion will occur on the upper arm
|
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 Comparator: Sham-remote ischemic preconditioning
Transient ischemic ischemia will not actually occur on the upper arm
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Myocardial injury after non-cardiac surgery (MINS)
Time Frame: 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
|
Within the first three days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Myocardial infarction
Time Frame: Within 30 days, 6 months, 1 year and 2 years of surgery
|
Number of participants with myocardial infarction
|
Within 30 days, 6 months, 1 year and 2 years of surgery
|
Major adverse cardiovascular events
Time Frame: Within 30 days, 6 months, 1 year and 2 years of surgery
|
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
Time Frame: Within 30 days, 6 months, 1 year and 2 years of surgery
|
Death related by cardiac reason
|
Within 30 days, 6 months, 1 year and 2 years of surgery
|
All deaths
Time Frame: Within 30 days, 6 months, 1 year and 2 years of surgery
|
All-cause death after surgery
|
Within 30 days, 6 months, 1 year and 2 years of surgery
|
Adverse events
Time Frame: Within 30 days after surgery
|
Adverse events
|
Within 30 days after surgery
|
Participants with the concentration of hs-cTnT reaching/above the prognostically important thresholds
Time Frame: Within the first three days after surgery
|
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
Time Frame: Within the first three days after surgery
|
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)
Time Frame: Within the first three days after surgery
|
Total hs-cTnT release
|
Within the first three days after surgery
|
Length of stay in the intensive care unit
Time Frame: expected 2 days after surgery
|
Length of intensive care unit stay
|
expected 2 days after surgery
|
Length of postoperative stay
Time Frame: expected 6 days after surgery
|
Length of hospital stay after surgery
|
expected 6 days after surgery
|
Major postoperative morbidity
Time Frame: Within 30 days after surgery
|
Major postoperative morbidity
|
Within 30 days after surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute kidney injury
Time Frame: Within 30 days after surgery
|
Acute kidney injury
|
Within 30 days after surgery
|
Postoperative pulmonary complications
Time Frame: Within 30 days after surgery
|
Postoperative pulmonary complications
|
Within 30 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yang Zhao, MD, Sixth SunYetSen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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. Erratum In: Lancet. 2013 Sep 14;382(9896):940.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 6, 2023
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
February 6, 2023
First Submitted That Met QC Criteria
February 14, 2023
First Posted (Actual)
February 17, 2023
Study Record Updates
Last Update Posted (Estimated)
February 21, 2024
Last Update Submitted That Met QC Criteria
February 19, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2022236
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
from 6 months to 36 months after publication
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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