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The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery

Primary Purpose

Aortic Valve Stenosis, Cardiopulmonary Bypass

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Blood pressure cuff inflation
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Remote ischemic preconditioning, Myocardial infarction, Cardiac surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôpital Laval

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Intervention group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in biochemical markers of myocardial ischemia
Troponin T-HS and CK-MB concentration

Secondary Outcome Measures

Post-operative complications
Monitoring the safety of the strategy by monitoring post-operative complications

Full Information

First Posted
September 28, 2017
Last Updated
March 9, 2023
Sponsor
Laval University
Collaborators
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
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1. Study Identification

Unique Protocol Identification Number
NCT03305094
Brief Title
The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery
Official Title
The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery : a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 11, 2014 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Cardiopulmonary Bypass
Keywords
Remote ischemic preconditioning, Myocardial infarction, Cardiac surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled prospective trial
Masking
Participant
Masking Description
Participant is blinded to group assignment
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm 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.
Arm Title
Intervention group
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Blood pressure cuff inflation
Intervention Description
Cuff pressure for ischemia sham is 20 mm Hg, ischemia is 200 mm Hg and reperfusion is 0 mm Hg
Primary Outcome Measure Information:
Title
Change in biochemical markers of myocardial ischemia
Description
Troponin T-HS and CK-MB concentration
Time Frame
6, 12, 24 and 48 hours post-operatively
Secondary Outcome Measure Information:
Title
Post-operative complications
Description
Monitoring the safety of the strategy by monitoring post-operative complications
Time Frame
post-operatively until 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Voisine, MD
Organizational Affiliation
University Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Laval
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery

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