Effect of Remote Ischemic Preconditioning in Patient Undergoing Cardiac Bypass Surgery
NCT ID: NCT00397163
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
200 participants
INTERVENTIONAL
2010-12-31
2017-01-13
Brief Summary
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The study hypothesis is: remote ischemic preconditioning will protect the heart and improve short-term clinical outcomes during coronary artery bypass graft surgery.
Detailed Description
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One such cardioprotective strategy is remote ischemic preconditioning(RIPC) which describes the cardioprotection obtained from inducing ischemia in tissue or an organ remote from the heart. Our laboratory and others have established RIPC using forearm ischemia (induced by an automated cuff applied to the upper arm) as an effective cardioprotective intervention in children undergoing corrective cardiac surgery for congenital heart disease and in adults undergoing CABG surgery. In this study we investigate whether simultaneous inflation/deflation of cuffs placed on the upper arm and thigh can reduce peri-operative myocardial injury and improve short-term outcomes in patients undergoing CABG surgery.
Eligible patients will be those patients undergoing elective CABG surgery who are \>18 years old, with no significant renal or hepatic disease, and have not had a recent AMI (within 1 month).
Consented patients will randomized to RIPC treatment or control.The RIPC protocol will comprise simultaneous 2 x 5 minutes of forearm and lower leg ischemia (with an automated pressure cuff inflated to 200 mmHg) with an intervening 5 minutes of reperfusion (during which the cuff is deflated) between each inflation. The control protocol will comprise a deflated cuff being placed on the upper arm and thigh for 20 minutes. The RIPC protocol will be implemented after the patients have been anesthetized and immediately prior to CABG surgery.
The measured endpoint of cardioprotection will be troponin-T release at 0, 12, 24, 48 and 72 hours following CABG surgery.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Remote preconditioning
Simultaneous inflation (5min) and deflation (5min) of cuffs placed on upper arm and thigh - cycle repeated 2 times
Remote ischemic preconditioning
Blood pressure cuff inflation
Placebo
Deflated cuffs placed on upperarm and thigh for 20 minutes
Placebo
Deflated cuff on upper arm and thigh for 20 min
Interventions
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Remote ischemic preconditioning
Blood pressure cuff inflation
Placebo
Deflated cuff on upper arm and thigh for 20 min
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Significant renal or hepatic disease
* Previous acute myocardial infarction (within 4 weeks)
18 Years
ALL
No
Sponsors
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University College London Hospitals
OTHER
Responsible Party
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Derek Yellon
Director of the Hatter Cardiovascular Institute
Principal Investigators
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Derek M Yellon, PhD DSc
Role: PRINCIPAL_INVESTIGATOR
The Hatter Cardiovascular Institute, UCL.
Locations
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The UCLH Heart Hospital, 14-16 Westmoreland St.
London, , United Kingdom
Countries
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References
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Kharbanda RK, Li J, Konstantinov IE, Cheung MM, White PA, Frndova H, Stokoe J, Cox P, Vogel M, Van Arsdell G, MacAllister R, Redington AN. Remote ischaemic preconditioning protects against cardiopulmonary bypass-induced tissue injury: a preclinical study. Heart. 2006 Oct;92(10):1506-11. doi: 10.1136/hrt.2004.042366. Epub 2006 Jul 3.
Loukogeorgakis SP, Panagiotidou AT, Broadhead MW, Donald A, Deanfield JE, MacAllister RJ. Remote ischemic preconditioning provides early and late protection against endothelial ischemia-reperfusion injury in humans: role of the autonomic nervous system. J Am Coll Cardiol. 2005 Aug 2;46(3):450-6. doi: 10.1016/j.jacc.2005.04.044.
Broadhead MW, Kharbanda RK, Peters MJ, MacAllister RJ. KATP channel activation induces ischemic preconditioning of the endothelium in humans in vivo. Circulation. 2004 Oct 12;110(15):2077-82. doi: 10.1161/01.CIR.0000144304.91010.F0. Epub 2004 Oct 4.
Kharbanda RK, Mortensen UM, White PA, Kristiansen SB, Schmidt MR, Hoschtitzky JA, Vogel M, Sorensen K, Redington AN, MacAllister R. Transient limb ischemia induces remote ischemic preconditioning in vivo. Circulation. 2002 Dec 3;106(23):2881-3. doi: 10.1161/01.cir.0000043806.51912.9b.
Kharbanda RK, Peters M, Walton B, Kattenhorn M, Mullen M, Klein N, Vallance P, Deanfield J, MacAllister R. Ischemic preconditioning prevents endothelial injury and systemic neutrophil activation during ischemia-reperfusion in humans in vivo. Circulation. 2001 Mar 27;103(12):1624-30. doi: 10.1161/01.cir.103.12.1624.
Cheung MM, Kharbanda RK, Konstantinov IE, Shimizu M, Frndova H, Li J, Holtby HM, Cox PN, Smallhorn JF, Van Arsdell GS, Redington AN. Randomized controlled trial of the effects of remote ischemic preconditioning on children undergoing cardiac surgery: first clinical application in humans. J Am Coll Cardiol. 2006 Jun 6;47(11):2277-82. doi: 10.1016/j.jacc.2006.01.066. Epub 2006 May 15.
Konstantinov IE, Li J, Cheung MM, Shimizu M, Stokoe J, Kharbanda RK, Redington AN. Remote ischemic preconditioning of the recipient reduces myocardial ischemia-reperfusion injury of the denervated donor heart via a Katp channel-dependent mechanism. Transplantation. 2005 Jun 27;79(12):1691-5. doi: 10.1097/01.tp.0000159137.76400.5d.
Kristiansen SB, Henning O, Kharbanda RK, Nielsen-Kudsk JE, Schmidt MR, Redington AN, Nielsen TT, Botker HE. Remote preconditioning reduces ischemic injury in the explanted heart by a KATP channel-dependent mechanism. Am J Physiol Heart Circ Physiol. 2005 Mar;288(3):H1252-6. doi: 10.1152/ajpheart.00207.2004. Epub 2004 Oct 21.
Konstantinov IE, Arab S, Kharbanda RK, Li J, Cheung MM, Cherepanov V, Downey GP, Liu PP, Cukerman E, Coles JG, Redington AN. The remote ischemic preconditioning stimulus modifies inflammatory gene expression in humans. Physiol Genomics. 2004 Sep 16;19(1):143-50. doi: 10.1152/physiolgenomics.00046.2004. Epub 2004 Aug 10.
Candilio L, Malik A, Ariti C, Barnard M, Di Salvo C, Lawrence D, Hayward M, Yap J, Roberts N, Sheikh A, Kolvekar S, Hausenloy DJ, Yellon DM. Effect of remote ischaemic preconditioning on clinical outcomes in patients undergoing cardiac bypass surgery: a randomised controlled clinical trial. Heart. 2015 Feb;101(3):185-92. doi: 10.1136/heartjnl-2014-306178. Epub 2014 Sep 24.
Venugopal V, Hausenloy DJ, Ludman A, Di Salvo C, Kolvekar S, Yap J, Lawrence D, Bognolo J, Yellon DM. Remote ischaemic preconditioning reduces myocardial injury in patients undergoing cardiac surgery with cold-blood cardioplegia: a randomised controlled trial. Heart. 2009 Oct;95(19):1567-71. doi: 10.1136/hrt.2008.155770. Epub 2009 Jun 8.
Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.
Other Identifiers
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01/0128
Identifier Type: -
Identifier Source: org_study_id