Cardiac Elastography Measurement : an Intraoperative Cardiac Surgery Study

• Conditions: Diastolic Dysfunction and Cardiac Stiffness

• Registration Number: NCT02051920
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-25
• Study Start: 2013-11
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-31
• Primary Completion: 2014-11
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-09
• Last Update Posted: 2015-01-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Young's Modulus measurement according to the equation E = Young 3ρCs ²	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 Outcome Measures

Name	Time	Method
diastolic function parameters	Day 0	Correlation between young's modulus and diastolic function parameters is assess after surgery by post processing

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, Basse Normandie, France