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

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

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.

Study Overview

• Status: Unknown
• Conditions: Diastolic Dysfunction and Cardiac Stiffness

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Eric Saloux, MD; Phone Number: +330231064901; Email: saloux-e@chu-caen.fr
• Study Contact Backup: Name: Fabrice Bauer, MD,PhD; Email: fabrice.bauer@chu-rouen.fr

Study Locations

• France
  • Basse Normandie
    • Caen, Basse Normandie, France, 14033
      • Recruiting
      • CAEN University Hospital
      • Principal Investigator: Eric saloux, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients undergoing cardiac surgery

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Young's Modulus measurement according to the equation E = Young 3ρCs ²	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	During herat surgery (Day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diastolic function parameters	Correlation between young's modulus and diastolic function parameters is assess after surgery by post processing	Day 0

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: University Hospital, Rouen
• Investigators: Study Director: Fabrice Bauer, MD,PhD, ROUEN university hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: October 25, 2013
• First Submitted That Met QC Criteria: January 29, 2014
• First Posted (Estimate): January 31, 2014

Study Record Updates

• Last Update Posted (Estimate): January 12, 2015
• Last Update Submitted That Met QC Criteria: January 9, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Elastography
• Other Study ID Numbers: REA-FO-2013-A00593-42