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

NCT03363958 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-12-06

No results posted yet for this study

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.

Conditions

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

Interventions

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.

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.

Sponsors & Collaborators

  • Medinet Heart Centre

    lead OTHER

Principal Investigators

  • Jakub S. Marczak, M.D. · Medinet Heart Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-01
Primary Completion
2019-01-01
Completion
2020-01-01

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03363958 on ClinicalTrials.gov