Effect of Ischemic Preconditioning in Patient Undergoing Cardiac Bypass Surgery - Tabular View

Tracking Information

First Received Date ^ICMJE

November 6, 2006

Last Updated Date

November 7, 2006

Start Date ^ICMJE

February 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00397163 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Effect of Ischemic Preconditioning in Patient Undergoing Cardiac Bypass Surgery

Official Title ^ICMJE

A Clinical Study Investigating Ischemic Preconditioning in Type II Diabetic Patients Undergoing Coronary Artery Bypass Graft Surgery.

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 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.

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Coronary Heart Disease

Intervention ^ICMJE

Procedure: Remote ischemic preconditioning

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

November 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Derek M Yellon, PhD DSc

0044 207 380 9888

d.yellon@ucl.ac.uk

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00397163

Responsible Party

Study ID Numbers ^ICMJE

01/0128

Study Sponsor ^ICMJE

University College London Hospitals

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Derek M Yellon, PhD DSc

The Hatter Cardiovascular Institute, UCL.

Information Provided By

University College London Hospitals

Verification Date

November 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP