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Cardiac Elastography Measurement : an Intraoperative Cardiac Surgery Study (REA-FO)

C

Caen University Hospital

Status

Unknown

Conditions

Diastolic Dysfunction and Cardiac Stiffness

Study type

Observational

Funder types

Other

Identifiers

NCT02051920
REA-FO-2013-A00593-42

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Fabrice Bauer, MD,PhD; Eric Saloux, MD

Data sourced from clinicaltrials.gov

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