Full Text View
Tabular View
No Study Results Posted
Related Studies
Effect of Ischemic Preconditioning in Patient Undergoing Cardiac Bypass Surgery
This study is currently recruiting participants.
Verified by University College London Hospitals, November 2006
First Received: November 6, 2006   Last Updated: November 7, 2006   History of Changes
Sponsored by: University College London Hospitals
Information provided by: University College London Hospitals
ClinicalTrials.gov Identifier: NCT00397163
  Purpose

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 a new concept in which the application of transient ischemia to the forearm (through the inflation of a blood pressure cuff on the right upper arm) may reduce the injury to the heart muscle sustained during cardiac surgery, a concept called remote ischemic postconditioning.

The study hypothesis is: remote ischemic preconditioning using forearm ischemia protects the heart during coronary artery bypass graft surgery.


Condition Intervention Phase
Coronary Heart Disease
Procedure: Remote ischemic preconditioning
Phase I

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title: A Clinical Study Investigating Ischemic Preconditioning in Type II Diabetic Patients Undergoing Coronary Artery Bypass Graft Surgery.

Resource links provided by NLM:


Further study details as provided by University College London Hospitals:

Primary Outcome Measures:
  • Troponin-T release over the perioperative 72-hour period.

Estimated Enrollment: 60
Study Start Date: February 2006
Estimated Study Completion Date: November 2006
Detailed Description:

Ischemic heart disease (IHD) is currently the leading cause of morbidity and mortality in the developed world, and is set to become the leading cause of death in the world by the year 2020, according to the World Health Organisation. Patients with severe IHD that require coronary artery bypass graft (CABG) surgery, although protected by techniques such as cross-clamp fibrillation and cardioplegia, still sustain significant myocardial injury as evidenced by perioperative troponin T or I or CK-MB release. Novel treatment strategies are required to limit the myocardial injury sustained by patients undergoing CABG surgery in order to improve the clinical outcomes of this patient group.

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.

However, this RIPC protocol has not previously been examined in adult patients undergoing elective CABG surgery.

Eligible patients will be those patients undergoing elective CABG surgery who are >18 years old, with no siginificant 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 3 x 5 minutes of forearm 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 for 30 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients undergoing elective CABG surgery

Exclusion Criteria:

  • <18 years old
  • Significant renal or hepatic disease
  • Previous acute myocardial infarction (within 4 weeks)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00397163

Contacts
Contact: Derek M Yellon, PhD DSc 0044 207 380 9888 d.yellon@ucl.ac.uk

Locations
United Kingdom
The UCLH Heart Hospital, 14-16 Westmoreland St. Recruiting
London, United Kingdom, W1G 8PH
Sponsors and Collaborators
University College London Hospitals
Investigators
Principal Investigator: Derek M Yellon, PhD DSc The Hatter Cardiovascular Institute, UCL.
  More Information

Publications:
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. 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.
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. 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.
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.
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. 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.
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. 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. Epub 2004 Aug 10.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: 01/0128
Study First Received: November 6, 2006
Last Updated: November 7, 2006
ClinicalTrials.gov Identifier: NCT00397163     History of Changes
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University College London Hospitals:
Coronary artery bypass graft surgery
Remote ischemic preconditioning
Troponin-T

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on September 01, 2009