Remote Ischemic Conditioning to Attenuate Myocardial Death and Improve Operative Outcome.
RICARDO
Effect of Remote Ischemic Conditioning on Ischemia and Reperfusion Injury in Patients Submitted to Coronary Artery Bypass Grafting.
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2014
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 30, 2017
CompletedFirst Posted
Study publicly available on registry
December 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedDecember 6, 2017
November 1, 2017
5 years
November 30, 2017
November 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Postoperative myocardial necrosis
Serial mesurements of High - Sensitive Troponin T release
72 hours postoperatively
Postoperative kidney injury
Serial measurements of estimated glomerular filtration rate by creatinine
7 days postoperatively
Secondary Outcomes (3)
Perioperative mortality
30 days postoperatively
Perioperative myocardial infarction
30 days postoperatively
Postoperative Acute Kidney Injury
30 days
Study Arms (2)
RIC Group
EXPERIMENTALThree 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.
Control Group
SHAM COMPARATORControl 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medinet Heart Centre
Nowa Sól, Lubusz Voivodeship, 67-100, Poland
Related 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.
PMID: 22286602BACKGROUND
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Jakub S. Marczak, M.D.
Medinet Heart Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2017
First Posted
December 6, 2017
Study Start
January 1, 2014
Primary Completion
January 1, 2019
Study Completion
January 1, 2020
Last Updated
December 6, 2017
Record last verified: 2017-11