Remote Ischemic Conditioning to Attenuate Myocardial Death and Improve Operative Outcome.
Sponsored by Medinet Heart Centre
About this trial
Last updated 8 years ago
Study ID
RIPC Trial
Status
Unknown
Type
Interventional
Phase
Phase 2
Placebo
No
Accepting
18 to 75 Years
All Sexes
Trial Timing
Ended 6 years ago
What is this trial about?
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.
What are the participation requirements?
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;