The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery

Not Applicable

Active, not recruiting

• Conditions: Aortic Valve Stenosis; Cardiopulmonary Bypass

• Registration Number: NCT03305094
• Lead Sponsor: Laval University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-11
• Study First Submitted: 2017-09-28
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-09
• Primary Completion: 2020-07-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-10
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in biochemical markers of myocardial ischemia	6, 12, 24 and 48 hours post-operatively	Troponin T-HS and CK-MB concentration

Secondary Outcome Measures

Name	Time	Method
Post-operative complications	post-operatively until 30 days	Monitoring the safety of the strategy by monitoring post-operative complications

Trial Locations

Locations (1)

Hôpital Laval; 🇨🇦 Quebec City, Quebec, Canada