Cardiac Elastography Measurement : an Intraoperative Cardiac Surgery Study

NCT ID: NCT02051920

Last Updated: 2015-01-12

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

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Brief Summary

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Since 20 years, the techniques of direct measurement of cardiac stiffness in the diagnosis of myocardial diseases do not exist.

We propose a human study evaluating the direct measurement of cardiac ultrasound stiffness by elastography.

This study will include 30 patients with cardiac disease whose rigidity varies with underlying disease.

The purpose of this study is to evaluate the stiffness during open heart surgery.

Detailed Description

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Conditions

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Diastolic Dysfunction and Cardiac Stiffness

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Written consent
* Patients older than 18 years
* Every patient scheduled for cardiac surgery
* Cardiac catheterization within 6 months before surgery,
* Women of childbearing age in effective contraception (a urine pregnancy test will be performed)
* Patient affiliated or covered by a plan of health insurance.
* Francophone

Exclusion Criteria

* Pregnant or lactating woman,
* Functional walking disability,
* Patient placed under judicial protection: guardianship,
* Patient participating in another trial and / or participated in another trial within two months,
* Patient under guardianship or trusteeship,
* Women who are not effective contraception,
* Patient with no liberty by administrative or judicial decision
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabrice Bauer, MD,PhD

Role: STUDY_DIRECTOR

University Hospital, Rouen

Locations

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Caen University Hospital

Caen, Basse Normandie, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Eric Saloux, MD

Role: CONTACT

+330231064901

Fabrice Bauer, MD,PhD

Role: CONTACT

Other Identifiers

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REA-FO-2013-A00593-42

Identifier Type: -

Identifier Source: org_study_id

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