Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397163
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2006-11-06
Brief Title:
Effect of Remote Ischemic Preconditioning in Patient Undergoing Cardiac Bypass Surgery
Sponsor:
University College London Hospitals
Organization:
University College London Hospitals
Study Overview
Official Title:
A Clinical Study Investigating Ischemic Preconditioning in Type II Diabetic Patients Undergoing Coronary Artery Bypass Graft Surgery
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
The study hypothesis is remote ischemic preconditioning will protect the heart and improve short-term clinical outcomes 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 preconditioningRIPC 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 inflationdeflation 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 controlThe 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
One such cardioprotective strategy is remote ischemic preconditioningRIPC 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 inflationdeflation 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 controlThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None