The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery

Sponsor

Laval University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03305094

Collaborator

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Other)

140

Enrollment

Location

Arms

115.7

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis Cardiopulmonary Bypass	Procedure: Blood pressure cuff inflation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled prospective trialRandomized controlled prospective trial

Masking:

Single (Participant)

Masking Description:

Participant is blinded to group assignment

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 11, 2014

Actual Primary Completion Date :

Jul 1, 2020

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Post-operative complications [post-operatively until 30 days]
Monitoring the safety of the strategy by monitoring post-operative complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Laval	Quebec City	Quebec	Canada	G1V 4G5

Sponsors and Collaborators

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

Investigators

Principal Investigator: Pierre Voisine, MD, University Laval

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pierre Voisine, Cardiac surgeon, Laval University

ClinicalTrials.gov Identifier:

NCT03305094

Other Study ID Numbers:

CONDOR-21082

First Posted:

Oct 9, 2017

Last Update Posted:

Aug 19, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pierre Voisine, Cardiac surgeon, Laval University

Remote ischemic preconditioning

Myocardial infarction

Cardiac surgery

Additional relevant MeSH terms:

Aortic Valve Stenosis

Study Results

No Results Posted as of Aug 19, 2022