Non-Invasive Quantitative Imaging of Human Local Arterial Wall Elasticity Using Supersonic Shear Imaging

Not Applicable

Completed

• Conditions: Vascular Ehlers Danlos Syndrome; Healthy Volunteers
• Interventions: Other: SSI and SphygmoCor® evaluations

• Registration Number: NCT01096264
• Lead Sponsor: French Cardiology Society

Brief Summary

Arterial stiffness is associated with increased risk of cardiovascular events and death.

Most of existing technique need dedicated device for arterial stiffness evaluation and indirect calculation of intra arterial pressure. Supersonic Shear Imaging (SSI) is a novel non-invasive technique based on remote palpation of biological tissues that can image with very high temporal resolution (up to 10,000 images/s) and quantify the local viscoelastic properties of tissues. The investigators goal was to apply this SSI technique for arterial stiffness evaluation and local pulse wave velocity (PWV) calculation.

As a first step, the primary goal of this study is to establish normal values of local pulse wave velocity and arterial stiffness (carotid and femoral) by SSI on hundred healthy volunteers.

Detailed Description

Provide a more extensive description, if desired. Avoid duplication of information to be recorded elsewhere, such as eligibility criteria or outcome measures.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-19
• Study First Submitted QC: 2010-03-30
• Study First Posted: 2010-03-31
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-06
• Last Update Posted: 2015-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Healthy volunteer	SSI and SphygmoCor® evaluations	Healthy volunteer undergoing two imagery evaluation : * SSI technique for local PWV and arterial stiffness evaluation * SphygmoCor® for aortic PWV.
vEDS patients	SSI and SphygmoCor® evaluations	vEDS patients undergoing two imagery evaluations: * SSI technique for local PWV and arterial stiffness evaluation * SphygmoCor® for aortic PWV.

Primary Outcome Measures

Name	Time	Method
Normal Values by SSI	day one	Normal Values by SSI of local PWV and arterial wall stiffness(carotid and femoral).

Secondary Outcome Measures

Name	Time	Method
Comparison between 2 populations of values by SSI	Day one	Comparison between healthy volunteers and vEDS patients for PWV and arterial stiffness evaluated by SSI.
repeatability of the "primary outcome measure"	Day one	Evaluation of the repeatability of the "primary outcome measure" on 100 healthy volunteers and 30 patients with Vascular Ehlers Danlos Syndrome (vEDS).
Comparison of values between SSI and standard gold	Day one	Concordance evaluation between PWV calculated by SSI and Aortic Pulse wave velocity calculated by ShygmoCor®

Trial Locations

Locations (1)

CIC - Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France