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NCT03305094 Clinical Trial

The Effect of Remote Ischemic Preconditioning in Aortic Valve Replacement Surgery

Aortic Valve Stenosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03305094
Other study ID # CONDOR-21082
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 11, 2014
Est. completion date December 1, 2024

Study information
Verified date March 2023
Source Laval University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 140
Est. completion date December 1, 2024
Est. primary completion date July 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Canada Hôpital Laval Quebec City Quebec

Sponsors (2)
Lead Sponsor Collaborator
Laval University Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in biochemical markers of myocardial ischemia Troponin T-HS and CK-MB concentration 6, 12, 24 and 48 hours post-operatively
Secondary Post-operative complications Monitoring the safety of the strategy by monitoring post-operative complications post-operatively until 30 days
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