Coronary Artery Bypass Clinical Trial
Official title:
Effect of Remote Ischemic Conditioning on Ischemia and Reperfusion Injury in Patients Submitted to Coronary Artery Bypass Grafting.
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.
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.
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