Effect of Remote Ischemic Preconditioning in Patient Undergoing Cardiac Bypass Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University College London Hospitals
Sponsor:
Information provided by (Responsible Party):
Derek Yellon, University College London Hospitals
ClinicalTrials.gov Identifier:
NCT00397163
First received: November 6, 2006
Last updated: June 26, 2013
Last verified: June 2013

November 6, 2006
June 26, 2013
December 2010
July 2012   (final data collection date for primary outcome measure)
Troponin-T release over the perioperative 72-hour period. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Troponin-T release over the perioperative 72-hour period.
Complete list of historical versions of study NCT00397163 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Effect of Remote Ischemic Preconditioning in Patient Undergoing Cardiac Bypass Surgery
A Clinical Study Investigating Ischemic Preconditioning in Type II Diabetic Patients Undergoing Coronary Artery Bypass Graft Surgery.

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.

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 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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Coronary Heart Disease
  • Procedure: Remote ischemic preconditioning
    Blood pressure cuff inflation
    Other Name: Remote Ischaemic Preconditioning
  • Procedure: Placebo
    Deflated cuff on upper arm and thigh for 20 min
    Other Name: Control
  • Active Comparator: Remote preconditioning
    Simultaneous inflation (5min) and deflation (5min) of cuffs placed on upper arm and thigh - cycle repeated 2 times
    Intervention: Procedure: Remote ischemic preconditioning
  • Placebo Comparator: Placebo
    Deflated cuffs placed on upperarm and thigh for 20 minutes
    Intervention: Procedure: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
November 2013
July 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Derek M Yellon, PhD DSc +44 203 447 9888 d.yellon@ucl.ac.uk
United Kingdom
 
NCT00397163
01/0128
Yes
Derek Yellon, University College London Hospitals
University College London Hospitals
Not Provided
Principal Investigator: Derek M Yellon, PhD DSc The Hatter Cardiovascular Institute, UCL.
University College London Hospitals
June 2013

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