Remote Ischemic Conditioning to Attenuate Myocardial Death and Improve Operative Outcome.

Coronary Artery Bypass Clinical Trial

— RICARDO  

Official title:

Effect of Remote Ischemic Conditioning on Ischemia and Reperfusion Injury in Patients Submitted to Coronary Artery Bypass Grafting.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03363958
• Other study ID #: RIPC Trial
• Status: Recruiting
• Phase: Phase 2
• First received: November 30, 2017
• Last updated: November 30, 2017
• Start date: January 1, 2014
• Est. completion date: January 1, 2020

Study information

• Verified date: November 2017
• Source: Medinet Heart Centre
• Contact: Jakub S. Marczak, M.D.
• Phone: 0048883774566
• Email: marczak[@]space.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Coronary Artery Bypass
• Ischemia
• Ischemic Postconditioning
• Ischemic Preconditioning, Myocardial
• Myocardial Reperfusion Injur

Intervention

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 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.

Locations

Country	Name	City	State
Poland	Medinet Heart Centre	Nowa Sol	Lubuskie

Sponsors (1)

Lead Sponsor	Collaborator
Medinet Heart Centre

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative myocardial necrosis	Serial mesurements of High - Sensitive Troponin T release	72 hours postoperatively
Primary	Postoperative kidney injury	Serial measurements of estimated glomerular filtration rate by creatinine	7 days postoperatively
Secondary	Perioperative mortality	30-day all cause mortality	30 days postoperatively
Secondary	Perioperative myocardial infarction	30-day myocardial infarction	30 days postoperatively
Secondary	Postoperative Acute Kidney Injury	Prevalence of acute kidney injury according to Society of Thoracic Surgeons definitions of outcomes.	30 days

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