Remote Ischemic Conditioning to Attenuate Myocardial Death and Improve Operative Outcome. (RICARDO)
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|ClinicalTrials.gov Identifier: NCT03363958|
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Bypass Myocardial Reperfusion Injur Ischemic Preconditioning, Myocardial Ischemic Postconditioning||Procedure: Remote Ischemic Preconditioning with Postconditioning Procedure: Sham RIPC procedure||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Remote Ischemic Conditioning on Ischemia and Reperfusion Injury in Patients Submitted to Coronary Artery Bypass Grafting.|
|Actual Study Start Date :||January 1, 2014|
|Estimated Primary Completion Date :||January 1, 2019|
|Estimated Study Completion Date :||January 1, 2020|
Experimental: RIC Group
Three cycles of remote ischemic conditioning (5minutes ischemia and 5minutes reperfusion; lower leg ischemia achieved by pressure cuff inflation and deflation); First three cycles the patient will receive 24 hours preoperatively, second three cycles the patient will receive after the induction of general anesthesia but before skin incision shortly before CABG. Remote ischemic postconditioning (5minutes ischemia and 5minutes reperfusion; lower leg ischemia achieved by pressure cuff inflation and deflation) will be administered to the patient within 60 minutes after the completion of all coronary artery bypass grafts and the restoration of coronary blood flow.
Procedure: Remote 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.
Sham Comparator: Control Group
Control group will receive sham procedure near identical to intervention. That will be afforded by inflation of pressure cuff on artificial leg hidden under the draping by an assistant who is not included in the research team and does not have any connection to study design and data analysis.
Procedure: Sham 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.
- Postoperative myocardial necrosis [ Time Frame: 72 hours postoperatively ]Serial mesurements of High - Sensitive Troponin T release
- Postoperative kidney injury [ Time Frame: 7 days postoperatively ]Serial measurements of estimated glomerular filtration rate by creatinine
- Perioperative mortality [ Time Frame: 30 days postoperatively ]30-day all cause mortality
- Perioperative myocardial infarction [ Time Frame: 30 days postoperatively ]30-day myocardial infarction
- Postoperative Acute Kidney Injury [ Time Frame: 30 days ]Prevalence of acute kidney injury according to Society of Thoracic Surgeons definitions of outcomes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363958
|Contact: Jakub S. Marczak, M.D.||firstname.lastname@example.org|
|Contact: Sleiman S. Aboul - Hassan, M.D.||email@example.com|
|Medinet Heart Centre||Recruiting|
|Nowa Sol, Lubuskie, Poland, 67-100|
|Contact: Sleiman Sebastian Aboul-Hassan, MD firstname.lastname@example.org|
|Principal Investigator:||Jakub S. Marczak, M.D.||Medinet Heart Center|