The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery

The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery : a Randomized Controlled Trial

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 Overview

• Status: Active, not recruiting
• Conditions: Aortic Valve Stenosis; Cardiopulmonary Bypass
• Intervention / Treatment: Procedure: Blood pressure cuff inflation

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Quebec City, Quebec, Canada, G1V 4G5
      • Hôpital Laval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Blood pressure cuff inflation; Cuff pressure for ischemia sham is 20 mm Hg, ischemia is 200 mm Hg and reperfusion is 0 mm Hg
Experimental: 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.	Procedure: Blood pressure cuff inflation; Cuff pressure for ischemia sham is 20 mm Hg, ischemia is 200 mm Hg and reperfusion is 0 mm Hg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative complications	Monitoring the safety of the strategy by monitoring post-operative complications	post-operatively until 30 days

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2014
• Primary Completion (Actual): July 1, 2020
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: October 3, 2017
• First Posted (Actual): October 9, 2017

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Myocardial infarction; Cardiac surgery; Remote ischemic preconditioning
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: CONDOR-21082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No