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Sponsored by: |
University College London Hospitals |
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Information provided by: | University College London Hospitals |
ClinicalTrials.gov Identifier: | NCT00397163 |
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 |
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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. |
Estimated Enrollment: | 60 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | November 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Derek M Yellon, PhD DSc | 0044 207 380 9888 | d.yellon@ucl.ac.uk |
United Kingdom | |
The UCLH Heart Hospital, 14-16 Westmoreland St. | Recruiting |
London, United Kingdom, W1G 8PH |
Principal Investigator: | Derek M Yellon, PhD DSc | The Hatter Cardiovascular Institute, UCL. |
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 |
Coronary artery bypass graft surgery Remote ischemic preconditioning Troponin-T |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |