Coronary Artery Bypass, Ischemic Postconditioning, Ischemic Preconditioning, Myocardial, Myocardial Reperfusion Injur
Conditions
Keywords
myocardial protection, remote ischemic preconditioning, remote ischemic postconditioning, cardiac surgery
Brief summary
This study evaluates the addition of remote ischemic preconditioning and postconditioning to standard myocardial protection protocol in patients submitted to off - pump coronary artery bypass grafting in a prospective, 1:1 randomized, double blind fashion. An interventional group will receive remote ischemic preconditioning 24-hours before OP-CABG, immediately before surgery and within 60 minutes following surgery by means of lower limb ischemia achieved by pressure cuff inflation, whereas control group will receive sham procedure perioperatively.
Detailed description
In a prospective, 1:1 randomized and double blind fashion, the study will evaluate the impact of remote ischemic preconditioning, both immediate and second window of protection (24 hours and immediately before surgery) with remote ischemic postconditiong on operative outcomes in patients submitted to coronary artery bypass grafting without use of extracorporeal circulation. Remote ischemic conditioning was found to provide protection against necrosis and apoptosis due to ischemia and reperfusion injury, a phenomenon observed during coronary artery bypass grafting. That in turn was associated with poor postoperative outcomes, predominantly poor survival. Remote ischemic preconditioning will be provided by repeated lower leg ischemia and reperfusion with pressure cuff inflation for five minutes and deflation for five minutes in three consecutive cycles. Remote ischemic preconditioning will be performed 24 hours before CABG and immediately before surgery. Remote ischemic postconditioning will be performed within 60 minutes following the last coronary artery bypass graft completion and the restoration of coronary blood flow. The study will assess clinical endpoints such as postoperative acute myocardial infarction (type 5 MI), postoperative mortality, postoperative renal failure and laboratory outcomes such as postoperative serial measurements of troponin T release or glomerular filtration rate as secondary outcomes.
Interventions
PROCEDURERemote Ischemic Preconditioning with Postconditioning
Three cycles of 5 minutes of ischemia and 5 minutes of reperfusion of lower leg 24 hours, immediately before surgery and within 60 minutes after the restoration of coronary blood flow postoperatively.
PROCEDURESham RIPC procedure
Three cycles of 5 minutes of inflation and 5 minutes of deflation of artificial lower leg immediately before surgery and within 60 minutes after the restoration of coronary blood flow postoperatively.
Sponsors
Medinet Heart Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Patients qualified to coronary artery bypass grafting according to ESC/EACTS Guidelines of myocardial revascularization, suffering from: * Multivessel coronary artery disease amenable for surgical treatment * Negative history of previous cardiac or vascular surgery in childhood and afterwards. * Negative history of active neoplastic disease, neither past medical history of oncological treatment * Patients with non insulin dependent diabetes mellitus treated chronically with oral derivatives of sulfonylourea such as but not limited to: glibenclamide.
Exclusion criteria
Patients suffering from acute insuficiency of any organ/ system and those suffering from end stage organ failure such as: * Chronic renal disease - KDOQI stage ≥ 3; * Chronic renal failure class A by Child - Pugh'a; * Chronic respiratory failure (type I and II according to Campbell et al. and type I according to Wood et al.); * Chronic intermittent claudication class 2A according to Fontaine;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative myocardial necrosis | 72 hours postoperatively | Serial mesurements of High - Sensitive Troponin T release |
| Postoperative kidney injury | 7 days postoperatively | Serial measurements of estimated glomerular filtration rate by creatinine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative mortality | 30 days postoperatively | 30-day all cause mortality |
| Perioperative myocardial infarction | 30 days postoperatively | 30-day myocardial infarction |
| Postoperative Acute Kidney Injury | 30 days | Prevalence of acute kidney injury according to Society of Thoracic Surgeons definitions of outcomes. |
Countries
Poland
Contacts
Primary ContactJakub S. Marczak, M.D.
Backup ContactSleiman S. Aboul - Hassan, M.D.
Outcome results
None listed