The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery

Laval University

Status: Active, not recruiting

Conditions: Aortic Valve Stenosis; Cardiopulmonary Bypass

Treatments: Procedure: Blood pressure cuff inflation

Study type: Interventional

Funder types: Other

Identifiers

NCT03305094

CONDOR-21082

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

140 participants in 2 patient groups

Control group

Active Comparator group

Description:

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.

Treatment:

Procedure: Blood pressure cuff inflation

Intervention group

Experimental group

Description:

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.

Treatment:

Procedure: Blood pressure cuff inflation