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Completed

NCT Number: NCT01406678

Remote Ischemic Preconditioning in Coronary Artery Bypass Grafting With Cold Crystalloid Cardioplegic Arrest

Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion reduces myocardial injury in patients undergoing on-pump coronary artery bypass (CABG) surgery with cross-clamp fibrillation or blood cardioplegia for myocardial protection. The present study assesses protection of heart, brain and kidney by RIPC under crystalloid cardioplegic arrest. The study also addresses safety and clinical outcome.

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Key information

Conditions

Myocardial Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Thoracic and Cardiovascular Surgery, West-German Heart Center, University Duisburg-Essen

Essen, 45122, Germany

About this study

Remote ischemic preconditioning (RIPC) protocol after induction of anesthesia and before skin incision consists of 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 minutes of reperfusion. For myocardial molecular analyses, left ventricular biopsies are taken before induction of cardioplegic cardiac arrest and at 10 minutes after aortic unclamping during reperfusion of the myocardium.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consecutive patients >18 years of age
  • Double- or triple-vessel coronary artery disease
  • Elective isolated first-time CABG
  • Combined valve surgery + CABG
  • Written informed consent

Exclusion criteria

  • Renal failure (creatinine ≥ 200 µmol/L)
  • Peripheral vascular disease affecting upper limbs
  • Preoperative inotropic support
  • Any kind of mechanical assist device
  • Acute or recent (<4 weeks) acute coronary syndromes
  • Any PCI (<6 weeks)
  • Any reasons for preoperative cTnI elevation
  • Emergency surgery
  • Redo surgery

Treatment and study plan

RIPC

Procedure

3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion

Other names: RIPC: Remote ischemic preconditioning, CABG: Coronary artery bypass grafting

Control

Procedure

Coronary artery bypass surgery without remote ischemic preconditioning protocol

Other names: Coronary artery bypass surgery

isoflurane+sufentanil anesthesia

Drug

Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. During extracorporal circulation patients receive isoflurane via a vaporizer incorporated in the extracorporeal gas supply in the same concentrations.

Other names: Isoflurane, (2-chloro-2-(difluoromethoxy)-1,1,1-trifluoro-ethane), Forane, Sufentanil, Sufenta, (R-30730)

Primary outcomes

  1. Perioperative extent of myocardial injury as measured by cardiac troponin I serum release over 72 hours after CABG surgery and its area under the curve (AUC).

    Time frame: 72 hours postoperatively after CABG surgery

Secondary outcomes

  1. All-cause mortality

    Time frame: 30 days and 1 year and complete follow-up after CABG surgery

  2. Major adverse cardiac and cerebrovascular events (MACCE)

    Time frame: at 30 days and 1 year and complete follow-up after CABG surgery

  3. Myocardial infarction

    Time frame: 30 days and 1 year and complete follow-up after CABG surgery

  4. Renal function

    Time frame: 72 hours post CABG

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study title

Effect of Remote Ischemic Preconditioning in Patients Undergoing On-pump Coronary Artery Bypass Graft Surgery With Crystalloid Cardioplegic Arrest

Important dates

Study start
2008
Primary completion
2018
Study completion
2020
First posted
Aug 1, 2011
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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