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

Primary Purpose

Aortic Valve Stenosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Control
Remote ischemic preconditioning
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital, Angers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Control

Remote ischemic preconditioning

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 6, 2011
Last Updated
October 23, 2012
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT01390129
Brief Title
Remote Ischemic Preconditioning in Aortic Valve Surgery
Acronym
RIP-Valve
Official Title
Remote Ischemic Preconditioning in Aortic Valve Surgery (RIP-Valve)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Title
Remote ischemic preconditioning
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
Deflated blood pressure cuff placed on upper arm for 30min
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic preconditioning
Intervention Description
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 Measure Information:
Title
Infarct size
Description
Infarct size as assessed by 72 hours area under curve serum troponin-I
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice Prunier, MD, PhD
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Angers
City
Angers
ZIP/Postal Code
49933
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27664804
Citation
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.
Results Reference
derived

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Remote Ischemic Preconditioning in Aortic Valve Surgery

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