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