The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery

Not Applicable

Active, not recruiting

• Conditions: Aortic Valve Stenosis; Cardiopulmonary Bypass
• Interventions: Procedure: Blood pressure cuff inflation

• 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

Arm && Interventions

Group	Intervention	Description
Control group	Blood pressure cuff inflation	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.
Intervention group	Blood pressure cuff inflation	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.

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