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

Not Applicable

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Sham; Procedure: Remote ischemic conditioning

• Registration Number: NCT01107184
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 191

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Sham	-
Postconditioning	Remote ischemic conditioning	The remote ischemic stimulus during cardiopulmonary bypass.
Preconditioning	Remote ischemic conditioning	The remote ischemic stimulus will be applied after induction of anaesthesia, but before cardiopulmonary bypass.
Pre and postconditioning	Remote ischemic conditioning	The remote ischemic stimulus will be applied twice, after induction of anaesthesia and during cardiopulmonary bypass.

Primary Outcome Measures

Name	Time	Method
Post-operative atrial fibrillation	72 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Academic Medical Center, University of Amsterdam; 🇳🇱 Amsterdam, Netherlands