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Clinical Trials/NCT02051920
NCT02051920
Unknown
Not Applicable

Measurement of Cardiac Elastography: an Intraoperative Cardiac Surgery Study. Cardiac Elastography in Vivo

University Hospital, Caen1 site in 1 country30 target enrollmentNovember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diastolic Dysfunction and Cardiac Stiffness
Sponsor
University Hospital, Caen
Enrollment
30
Locations
1
Primary Endpoint
Young's Modulus measurement according to the equation E = Young 3ρCs ²
Last Updated
11 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
November 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Young's Modulus measurement according to the equation E = Young 3ρCs ²

Time Frame: During herat surgery (Day 0)

Ultrasound acquisition will be completed in epicardial vue using a linear probe SuperLinear 15-4 ™ connected to an ultrasound (AixplorerTM ® from Supersonic Imagine). The acquisitions will be completed in mode B + Elastrography Shear Wave ™ (SWE). A sterile gel is deposited in the bottom of the pouch of sterile protection of the probe. Many measurements will be done on accessible left and right ventricle areas. Measurement of Young's modulus: automated by the onboard model according to the equation E = Young 3ρCs ², where E is the Young's elastic modulus software, ρ is the tissue density and Cs the velocity of shear wave

Secondary Outcomes

  • diastolic function parameters(Day 0)

Study Sites (1)

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