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
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.
Study Type
Interventional
Primary Outcome
Change in biochemical markers of myocardial ischemia
Secondary Outcome
Post-operative complications
Condition
Aortic Valve Stenosis
Intervention
Blood pressure cuff inflation
Study Arms / Comparison Groups
Control group
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
140
Start Date
April 11, 2014
Completion Date
December 1, 2020
Primary Completion Date
July 1, 2020
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pierre Voisine, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT03305094
Organization ID
CONDOR-21082
Responsible Party
Principal Investigator
Study Sponsor
Laval University
Collaborators
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Study Sponsor
Pierre Voisine, MD, Principal Investigator, University Laval
Verification Date
April 2020