The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery

NCT ID: NCT03305094

Last Updated: 2023-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-11
• Study Completion Date: 2024-12-01

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.

Conditions

Aortic Valve Stenosis; Cardiopulmonary Bypass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

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.

Group Type: ACTIVE_COMPARATOR

Blood pressure cuff inflation

Intervention Type: PROCEDURE

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

Intervention group

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.

Group Type: EXPERIMENTAL

Blood pressure cuff inflation

Intervention Type: PROCEDURE

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

Interventions

Blood pressure cuff inflation

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Pierre Voisine

Cardiac surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pierre Voisine, MD

Role: PRINCIPAL_INVESTIGATOR

University Laval

Locations

Hôpital Laval

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

CONDOR-21082

Identifier Type: -

Identifier Source: org_study_id