Status:
UNKNOWN
Remote Ischemic Conditioning to Attenuate Myocardial Death and Improve Operative Outcome.
Lead Sponsor:
Medinet Heart Centre
Conditions:
Coronary Artery Bypass
Myocardial Reperfusion Injur
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
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 immediate...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03363958
Start Date
January 1 2014
End Date
January 1 2020
Last Update
December 6 2017
Active Locations (1)
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1
Medinet Heart Centre
Nowa Sól, Lubusz Voivodeship, Poland, 67-100