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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Preconditioning

The remote ischemic stimulus will be applied after induction of anaesthesia, but before cardiopulmonary bypass.

Group Type EXPERIMENTAL

Remote ischemic conditioning

Intervention Type PROCEDURE

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.

Postconditioning

The remote ischemic stimulus during cardiopulmonary bypass.

Group Type EXPERIMENTAL

Remote ischemic conditioning

Intervention Type PROCEDURE

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.

Pre and postconditioning

The remote ischemic stimulus will be applied twice, after induction of anaesthesia and during cardiopulmonary bypass.

Group Type EXPERIMENTAL

Remote ischemic conditioning

Intervention Type PROCEDURE

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.

Control

Group Type SHAM_COMPARATOR

Sham

Intervention Type PROCEDURE

Patients will have a automated inflator cuff placed on the upper arm during surgery which will not be inflated.

Interventions

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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.

Intervention Type PROCEDURE

Sham

Patients will have a automated inflator cuff placed on the upper arm during surgery which will not be inflated.

Intervention Type PROCEDURE

Other Intervention Names

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Remote ischemic preconditioning Remote ischemic postconditioning

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No