The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery

Study Overview
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Brief Summary
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The study objective is to verify if a non-invasive remote ischemic preconditioning procedure (blood pressure cuff on the arm) is cardioprotective when applied before an aortic valve replacement surgery.

Official Title
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The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery : a Randomized Controlled Trial

Conditions
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Aortic Valve Stenosis, Cardiopulmonary Bypass

Intervention / Treatment
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* Procedure: Blood pressure cuff inflation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned isolated aortic valve replacement (stenosis based) Age ≥ 18 years Exclusion Criteria: Pregnancy Left ventricular dysfunction (LVEF< 50%) Myocardial Infarct (< 7days) Coronary artery disease (documented with >50% stenosis) Coronary artery bypass grafting Chronic renal insufficiency (creatinine >175 mmol/L or dialysis) Endocarditis Sternotomy redo Deep vein thrombosis to the compressed limb Emergency procedure TAVI procedure Planned off pump coronary artery bypass MAZE procedure

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled prospective trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Sham remote ischemic preconditioning on the right arm is induced with a blood pressure cuff inflation at 20 mm Hg for 5 min and followed by a 5 min reperfusion at 0 mm Hg. The sham ischemia-reperfusion cycle is performed 3 times for a total of 30 min. This procedure is done after anesthetic induction, but before the patient is placed on cardiopulmonary bypass. A 20 mm Hg blood pressure cuff on the right arm does not induce ischemia. | Procedure: Blood pressure cuff inflation<br>* Cuff pressure for ischemia sham is 20 mm Hg, ischemia is 200 mm Hg and reperfusion is 0 mm Hg<br>|
| Experimental: Intervention group<br>Remote ischemic preconditioning on the right arm is induced with a blood pressure cuff inflation at 200 mm Hg for 5 min and followed by a 5 min reperfusion at 0 mm Hg. The ischemia-reperfusion cycle is performed 3 times for a total of 30 min. This procedure is done after anesthetic induction, but before the patient is placed on cardiopulmonary bypass. | Procedure: Blood pressure cuff inflation<br>* Cuff pressure for ischemia sham is 20 mm Hg, ischemia is 200 mm Hg and reperfusion is 0 mm Hg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in biochemical markers of myocardial ischemia | Troponin T-HS and CK-MB concentration | 6, 12, 24 and 48 hours post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative complications | Monitoring the safety of the strategy by monitoring post-operative complications | post-operatively until 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remote ischemic preconditioning, Myocardial infarction, Cardiac surgery