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
  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 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.


Condition Intervention Phase
Coronary Heart Disease
Procedure: Remote ischemic preconditioning
Procedure: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2010
Estimated Study Completion Date: November 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Remote preconditioning
Simultaneous inflation (5min) and deflation (5min) of cuffs placed on upper arm and thigh - cycle repeated 2 times
Procedure: Remote ischemic preconditioning
Blood pressure cuff inflation
Other Name: Remote Ischaemic Preconditioning
Placebo Comparator: Placebo
Deflated cuffs placed on upperarm and thigh for 20 minutes
Procedure: Placebo
Deflated cuff on upper arm and thigh for 20 min
Other Name: Control

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 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397163

Contacts
Contact: Derek M Yellon, PhD DSc +44 203 447 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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Derek Yellon, Director of Hatter Institute, University College London Hospitals
ClinicalTrials.gov Identifier: NCT00397163     History of Changes
Other Study ID Numbers: 01/0128
Study First Received: November 6, 2006
Last Updated: June 26, 2013
Health Authority: United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 23, 2014