A Clinical Study on the Effect of Remote Ischemic Conditioning on Atrial Fibrillation and Outcome After Coronary Artery Bypass Grafting
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 191
- Locations
- 1
- Primary Endpoint
- Post-operative atrial fibrillation
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Preconditioning
The remote ischemic stimulus will be applied after induction of anaesthesia, but before cardiopulmonary bypass.
Intervention: Remote ischemic conditioning (Procedure)
Postconditioning
The remote ischemic stimulus during cardiopulmonary bypass.
Intervention: Remote ischemic conditioning (Procedure)
Pre and postconditioning
The remote ischemic stimulus will be applied twice, after induction of anaesthesia and during cardiopulmonary bypass.
Intervention: Remote ischemic conditioning (Procedure)
Control
Intervention: Sham (Procedure)
Outcomes
Primary Outcomes
Post-operative atrial fibrillation
Time Frame: 72 hours
Secondary Outcomes
- Major cardiovascular and cerebrovascular events(3 months, 6 months, 1 year)
- Length of stay(1 week on avarage)
Investigators
B Preckel
Prof. dr. B. Preckel
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)