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CompletedNCT01390129RIP-ValveUpdated Oct 24, 2012

Remote Ischemic Preconditioning in Aortic Valve Surgery

An interventional study of Control and Remote ischemic preconditioning in Aortic Valve Stenosis, sponsored by University Hospital, Angers. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-24.

Sponsored by University Hospital, Angers · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Aortic Valve Stenosis

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03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's enrollment of 100 is below the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age > 18
  • Aortic valve surgery for aortic stenosis
  • Written informed consent

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Control

    Procedure: Control

  • Active comparator
    Remote ischemic preconditioning

    Procedure: Remote ischemic preconditioning

Interventions

  • ProcedureControl

    Deflated blood pressure cuff placed on upper arm for 30min

  • ProcedureRemote 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

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What researchers measure

Primary outcomes

  1. Infarct size

    Infarct size as assessed by 72 hours area under curve serum troponin-I

    Time frame: 72 hours

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Study locations

1 site
  • University Hospital, Angers
    Angers, 49933, France
08

References and documents

Publications

  • Chao de la Barca JM, Bakhta O, Kalakech H, Simard G, Tamareille S, Catros V, Callebert J, Gadras C, Tessier L, Reynier P, Prunier F, Mirebeau-Prunier D. Metabolic Signature of Remote Ischemic Preconditioning Involving a Cocktail of Amino Acids and Biogenic Amines. J Am Heart Assoc. 2016 Sep 24;5(9):e003891. doi: 10.1161/JAHA.116.003891. PubMed 27664804 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01390129
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Jul 8, 2011
Start date
Jul 2011
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Oct 24, 2012

Study contacts

Fabrice Prunier, MD, PhD
principal investigator · University Hospital, Angers

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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