NCT00397163

Brief Summary

During coronary artery bypass graft surgery, injury occurs to the heart muscle. Some of this injury is due to the deprivation of oxygen and nutrients to the heart (a process called ischemia) during the surgery itself. The objective of this study is to examine whether remote ischaemic preconditioning (RIPC), in which the application of transient ischemia to the forearm and thigh (through the inflation of blood pressure cuffs placed on the right upper arm and upper thigh) may reduce the injury to the heart muscle sustained during cardiac surgery. The study hypothesis is: remote ischemic preconditioning will protect the heart and improve short-term clinical outcomes during coronary artery bypass graft surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2006

Completed
4.1 years until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2017

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

6.1 years

First QC Date

November 6, 2006

Last Update Submit

November 28, 2023

Conditions

Coronary Heart Disease

Keywords

Coronary artery bypass graft surgeryRemote ischemic preconditioningTroponin-T

Outcome Measures

Primary Outcomes (1)

  • Troponin-T release over the perioperative 72-hour period.

    3 days

Study Arms (2)

Remote preconditioning

ACTIVE COMPARATOR

Simultaneous inflation (5min) and deflation (5min) of cuffs placed on upper arm and thigh - cycle repeated 2 times

Procedure: Remote ischemic preconditioning

Placebo

PLACEBO COMPARATOR

Deflated cuffs placed on upperarm and thigh for 20 minutes

Procedure: Placebo

Interventions

Remote ischemic preconditioningPROCEDURE

Blood pressure cuff inflation

Also known as: Remote Ischaemic Preconditioning
Remote preconditioning
PlaceboPROCEDURE

Deflated cuff on upper arm and thigh for 20 min

Also known as: Control
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients undergoing elective CABG surgery

You may not qualify if:

  • \<18 years old
  • Significant renal or hepatic disease
  • Previous acute myocardial infarction (within 4 weeks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The UCLH Heart Hospital, 14-16 Westmoreland St.

London, W1G 8PH, United Kingdom

Location

Related Publications (12)

  • 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.

    PMID: 16818489BACKGROUND

  • 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.

    PMID: 16053957BACKGROUND

  • 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.

    PMID: 15466634BACKGROUND

  • 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.

    PMID: 12460865BACKGROUND

  • 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.

    PMID: 11273988BACKGROUND

  • 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.

    PMID: 16750696BACKGROUND

  • 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.

    PMID: 15973170BACKGROUND

  • 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.

    PMID: 15498829BACKGROUND

  • 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.

    PMID: 15304621BACKGROUND

  • 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.

    PMID: 25252696DERIVED

  • 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.

    PMID: 19508973DERIVED

  • 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.

    PMID: 17707752DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Derek M Yellon, PhD DSc

    The Hatter Cardiovascular Institute, UCL.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Hatter Cardiovascular Institute

Study Record Dates

First Submitted

November 6, 2006

First Posted

November 8, 2006

Study Start

December 1, 2010

Primary Completion

January 13, 2017

Study Completion

January 13, 2017

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

GB(1)