Brief Title
Remote Ischemic Preconditioning in Aortic Valve Surgery
Official Title
Remote Ischemic Preconditioning in Aortic Valve Surgery (RIP-Valve)
Brief Summary
RIP-VALVE is a randomized, single blinded study that will test the hypothesis that remote ischemic preconditioning initiated before surgery reduces post-operative myocardial damage in aortic valve surgery. Infarct size will be determined by 72 hours area under curve of troponin-I.
Detailed Description
The hypothesis tested in this research proposal is that remote ischemic preconditioning initiated immediately before aortic valve surgery reduces myocardial damage related to surgery.
Study Type
Interventional
Primary Outcome
Infarct size
Condition
Aortic Valve Stenosis
Intervention
Control
Study Arms / Comparison Groups
Control
Description:
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
100
Start Date
July 2011
Completion Date
October 2012
Primary Completion Date
October 2012
Eligibility Criteria
Inclusion Criteria: - Age > 18 - Aortic valve surgery for aortic stenosis - Written informed consent Exclusion Criteria: - Aortic valve surgery combined with CABG or an other valve surgery - Previous Q-wave myocardial infarction or previous coronary artery bypass graft - Coronary artery stenosis >70% - Ejection fraction <35% - Surgery performed in emergency - Nicorandil ou metformin treatment within 8 days before surgery - Patient refusal / patient not having provided written informed consent.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Fabrice Prunier, MD, PhD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT01390129
Organization ID
AOI 2010-07
Responsible Party
Sponsor
Study Sponsor
University Hospital, Angers
Study Sponsor
Fabrice Prunier, MD, PhD, Principal Investigator, University Hospital, Angers
Verification Date
October 2012