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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
Sponsor:
Information provided by (Responsible Party):
Medinet Heart Centre

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.

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

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Postoperative myocardial necrosis [ Time Frame: 72 hours postoperatively ]
    Serial mesurements of High - Sensitive Troponin T release

  2. Postoperative kidney injury [ Time Frame: 7 days postoperatively ]
    Serial measurements of estimated glomerular filtration rate by creatinine


Secondary Outcome Measures :
  1. Perioperative mortality [ Time Frame: 30 days postoperatively ]
    30-day all cause mortality

  2. Perioperative myocardial infarction [ Time Frame: 30 days postoperatively ]
    30-day myocardial infarction

  3. Postoperative Acute Kidney Injury [ Time Frame: 30 days ]
    Prevalence of acute kidney injury according to Society of Thoracic Surgeons definitions of outcomes.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

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


Contacts
Contact: Jakub S. Marczak, M.D. 0048883774566 marczak@space.pl
Contact: Sleiman S. Aboul - Hassan, M.D. 0048683882194 s.aboulhassan@gmail.com

Locations
Poland
Medinet Heart Centre Recruiting
Nowa Sol, Lubuskie, Poland, 67-100
Contact: Sleiman Sebastian Aboul-Hassan, MD       s.aboulhassan@gmail.com   
Sponsors and Collaborators
Medinet Heart Centre
Investigators
Principal Investigator: Jakub S. Marczak, M.D. Medinet Heart Center

Additional Information:
Publications:
Responsible Party: Medinet Heart Centre
ClinicalTrials.gov Identifier: NCT03363958     History of Changes
Other Study ID Numbers: RIPC Trial
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medinet Heart Centre:
myocardial protection
remote ischemic preconditioning
remote ischemic postconditioning
cardiac surgery

Additional relevant MeSH terms:
Ischemia
Pathologic Processes