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

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ClinicalTrials.gov Identifier: NCT01390129
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : October 24, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Procedure: Control Procedure: Remote ischemic preconditioning Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Remote Ischemic Preconditioning in Aortic Valve Surgery (RIP-Valve)
Study Start Date : July 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390129


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01390129     History of Changes
Other Study ID Numbers: AOI 2010-07
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: October 24, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction