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Remote Ischemic Preconditioning in Aortic Valve Surgery (RIP-Valve)

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Angers Identifier:
First received: July 6, 2011
Last updated: October 23, 2012
Last verified: October 2012
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.

Condition Intervention
Aortic Valve Stenosis
Procedure: Control
Procedure: Remote ischemic preconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Remote Ischemic Preconditioning in Aortic Valve Surgery (RIP-Valve)

Resource links provided by NLM:

Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • Infarct size [ Time Frame: 72 hours ]
    Infarct size as assessed by 72 hours area under curve serum troponin-I

Enrollment: 100
Study Start Date: July 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Control Procedure: Control
Deflated blood pressure cuff placed on upper arm for 30min
Active Comparator: Remote ischemic preconditioning Procedure: Remote ischemic preconditioning
Blood pressure cuff placed on upper arm and inflated to 200 mmHg for 5 min and then deflated for 5 min. This cycle is initiated before aortic clamping and repeated 3 times in total

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01390129

University Hospital, Angers
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers
Principal Investigator: Fabrice Prunier, MD, PhD University Hospital, Angers
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Angers Identifier: NCT01390129     History of Changes
Other Study ID Numbers: AOI 2010-07
Study First Received: July 6, 2011
Last Updated: October 23, 2012

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction processed this record on March 24, 2017