Remote Ischemic Preconditioning in Aortic Valve Surgery

NCT ID: NCT01390129

Last Updated: 2012-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-10-31

Brief Summary

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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

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The hypothesis tested in this research proposal is that remote ischemic preconditioning initiated immediately before aortic valve surgery reduces myocardial damage related to surgery.

Conditions

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Aortic Valve Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Group Type EXPERIMENTAL

Control

Intervention Type PROCEDURE

Deflated blood pressure cuff placed on upper arm for 30min

Remote ischemic preconditioning

Group Type ACTIVE_COMPARATOR

Remote ischemic preconditioning

Intervention Type PROCEDURE

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

Interventions

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Control

Deflated blood pressure cuff placed on upper arm for 30min

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabrice Prunier, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

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University Hospital, Angers

Angers, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 27664804 (View on PubMed)

Other Identifiers

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AOI 2010-07

Identifier Type: -

Identifier Source: org_study_id