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Clinical Trials/NCT03305094
NCT03305094
Active, not recruiting
Not Applicable

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

Laval University1 site in 1 country140 target enrollmentApril 11, 2014
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ConditionsAortic Valve StenosisCardiopulmonary Bypass

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Valve Stenosis
Sponsor
Laval University
Enrollment
140
Locations
1
Primary Endpoint
Change in biochemical markers of myocardial ischemia
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 11, 2014
End Date
December 1, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pierre Voisine

Cardiac surgeon

Laval University

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

Outcomes

Primary Outcomes

Change in biochemical markers of myocardial ischemia

Time Frame: 6, 12, 24 and 48 hours post-operatively

Troponin T-HS and CK-MB concentration

Secondary Outcomes

  • Post-operative complications(post-operatively until 30 days)

Study Sites (1)

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