The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery

Laval University140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

140

Conditions

Aortic Valve Stenosis Cardiopulmonary Bypass

Interventions

Blood pressure cuff inflationPROCEDURE

Cuff pressure for ischemia sham is 20 mm Hg, ischemia is 200 mm Hg and reperfusion is 0 mm Hg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Laval

Québec, Quebec, Canada

Outcomes

Primary Outcomes

Change in biochemical markers of myocardial ischemia

Troponin T-HS and CK-MB concentration

Time frame: 6, 12, 24 and 48 hours post-operatively

Secondary Outcomes

Post-operative complications

Monitoring the safety of the strategy by monitoring post-operative complications

Time frame: post-operatively until 30 days

Data from ClinicalTrials.gov

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