Remote Ischemic Conditioning and Atrial Fibrillation After Coronary Artery Bypass Grafting (CABG)


Recent studies indicate that remote ischemic conditioning can protect the heart and other organs during cardiac surgery. The investigators aim to investigate whether such a stimulus can reduce the incidence of atrial fibrillation or other complications following coronary artery bypass surgery.

Full Title of Study: “A Clinical Study on the Effect of Remote Ischemic Conditioning on Atrial Fibrillation and Outcome After Coronary Artery Bypass Grafting”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2016


  • Procedure: Remote ischemic conditioning
    • Patients will have a automated inflator cuff placed on the upper arm during surgery. The cuff will be used to induce fore arm ischemia by inflation to 200 mmHg for 3 x 5 minutes, interspersed with 5 minutes of no-inflation and thus reperfusion.
  • Procedure: Sham
    • Patients will have a automated inflator cuff placed on the upper arm during surgery which will not be inflated.

Arms, Groups and Cohorts

  • Experimental: Preconditioning
    • The remote ischemic stimulus will be applied after induction of anaesthesia, but before cardiopulmonary bypass.
  • Experimental: Postconditioning
    • The remote ischemic stimulus during cardiopulmonary bypass.
  • Experimental: Pre and postconditioning
    • The remote ischemic stimulus will be applied twice, after induction of anaesthesia and during cardiopulmonary bypass.
  • Sham Comparator: Control

Clinical Trial Outcome Measures

Primary Measures

  • Post-operative atrial fibrillation
    • Time Frame: 72 hours

Secondary Measures

  • Major cardiovascular and cerebrovascular events
    • Time Frame: 3 months, 6 months, 1 year
    • Major adverse events, i.e. death, acute coronary syndrome, stroke.
  • Length of stay
    • Time Frame: 1 week on avarage
    • Duration of hospitalization and stay on the ICU

Participating in This Clinical Trial

Inclusion Criteria

  • Elective on-pump CABG surgery – Informed consent Exclusion Criteria:

  • Prior cardiac surgery (Re-operations) – Prior atrial fibrillation – Use of class 1 or 3 anti arrhythmic medication or digoxin Use of intermittent aortic cross clamping during surgery – Age <18 years – Left ventricular ejection fraction ≤30% – Serious pulmonary disease (resting pO2 <90% at room air) – Renal failure (clearance <30 ml/min as calculated using the Modification of Diet in Renal Disease formula) – Liver failure – Use of the sulfonylurea derivative glibenclamide (this drug is known to block any preconditioning stimulus

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Academisch Medisch Centrum – Universiteit van Amsterdam (AMC-UvA)
  • Provider of Information About this Clinical Study
    • Principal Investigator: B Preckel, Prof. dr. B. Preckel – Academisch Medisch Centrum – Universiteit van Amsterdam (AMC-UvA)
  • Overall Official(s)
    • Stef de Hert, Md, PhD, Principal Investigator, Academisch Medisch Centrum – Universiteit van Amsterdam (AMC-UvA)

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