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

Study Overview
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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.

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Remote ischemic conditioning
* Procedure: Sham


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preconditioning<br>The remote ischemic stimulus will be applied after induction of anaesthesia, but before cardiopulmonary bypass. | Procedure: Remote ischemic conditioning<br>* 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.<br>* Other names: Remote ischemic postconditioning;|
| Experimental: Postconditioning<br>The remote ischemic stimulus during cardiopulmonary bypass. | Procedure: Remote ischemic conditioning<br>* 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.<br>* Other names: Remote ischemic postconditioning;|
| Experimental: Pre and postconditioning<br>The remote ischemic stimulus will be applied twice, after induction of anaesthesia and during cardiopulmonary bypass. | Procedure: Remote ischemic conditioning<br>* 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.<br>* Other names: Remote ischemic postconditioning;|
| Sham Comparator: Control<br> | Procedure: Sham<br>* Patients will have a automated inflator cuff placed on the upper arm during surgery which will not be inflated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative atrial fibrillation |  | 72 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remote ischemic conditioning, CABG surgery, Atrial fibrillation, Coronary Artery Bypass, Ischemic Preconditioning