Clinical trial NCT03363958: Remote Ischemic Conditioning to Attenuate Myocardial Death and Improve Operative Outcome.
Official title: Effect of Remote Ischemic Conditioning on Ischemia and Reperfusion Injury in Patients Submitted to Coronary Artery Bypass Grafting.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Coronary Artery Bypass
Myocardial Reperfusion Injur
Ischemic Preconditioning, Myocardial
Ischemic Postconditioning
Keywords: myocardial protection
remote ischemic preconditioning
remote ischemic postconditioning
cardiac surgery
Lead sponsor: Medinet Heart Centre
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Postoperative myocardial necrosis
timeFrame: 72 hours postoperatively
measure: Postoperative kidney injury
timeFrame: 7 days postoperatively
Secondary outcomes:
measure: Perioperative mortality
timeFrame: 30 days postoperatively
measure: Perioperative myocardial infarction
timeFrame: 30 days postoperatively
measure: Postoperative Acute Kidney Injury
timeFrame: 30 days
Other outcomes:
Locations:
city: Nowa Sol
country: Poland
facility: Medinet Heart Centre
state: Lubuskie
Study officials:
affiliation: Medinet Heart Center
name: Jakub S. Marczak, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marczak J, Nowicki R, Kulbacka J, Saczko J. Is remote ischaemic preconditioning of benefit to patients undergoing cardiac surgery? Interact Cardiovasc Thorac Surg. 2012 May;14(5):634-9. doi: 10.1093/icvts/ivr123. Epub 2012 Jan 26.