Clinical trial NCT01096264: Non-Invasive Quantitative Imaging of Human Local Arterial Wall Elasticity Using Supersonic Shear Imaging
Official title: Establishment of Local Arterial Stiffness Normal Values (Carotid and Femoral) on Healthy Volunteers Using Supersonic Shear Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Vascular Ehlers Danlos Syndrome
Keywords: Arterial stiffness
Pulse wave velocity
Ultrafastecho
Supersonic shear imaging
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
Collaborators: name: National Research Agency, France
name: SOCIETE FRANCAISE DE MEDECINE VASCULAIRE
First posted: 2010-03-31
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL

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.

Eligibility criteria: Inclusion criteria for Healthy Volunteers

* Healthy volunteers between 18 and 70 years old of two sexes.
* Caucasian origin
* No tobacco or stopped for more than 5 years
* BMI between 18 and 30 kg/m2.
* Blood pressure after 5 minutes of rest \< 140 and 90 mmHg.
* Biological test (haematological biochemistry test in blood , urine test and toxicology tests are all normal) ECG, Blood pressure and Heart rhythm normal.
* All volunteers received information on the research and signed the consent form.
* Health system protection required

Inclusion criteria for patient :

* Age between, 18 et 70 years old for the two sexes
* Presence of two major criteria of Villefranche classification (Am J Med Genet 1998 ;77:31-7) and/or heterozygote pathogen mutation of COL3A1 gene.
* At least 4cm long normal arterial segment (carotid or femoral) analyzed by mode B echograph.
* All patient received information on the research and signed the consent form.
* Health system protection required

General Exclusion Criteria :

* Pregnancy
* Echograph gel allergy
* Local Artery disease (dissection or thrombosis)
* Arrhythmia
* No health insurance coverage
* Incapacity or refused to sign the consent form

Exclusion criteria for Healthy volunteers

* Acute or Chronic Systemic disease (atherosclerosis)
* Alcohol abuse or drug abuse (cocaine,cannabis,etc..)
* Active or past tobacco
* Hypercholesterolemia (LDLc \>1.09 g/l)
* Exclusion period according to the national record for volunteer of clinical trial.

Exclusion criteria for Patients

* No intact (carotid or femoral) segment for SSI analysis
* AT2 inhibitors or Beta blockers treatment will be notified but are not considered as exclusion criteria.

Primary outcomes:
measure: Normal Values by SSI
timeFrame: day one
Secondary outcomes:
measure: repeatability of the "primary outcome measure"
timeFrame: Day one
measure: Comparison between 2 populations of values by SSI
timeFrame: Day one
measure: Comparison of values between SSI and standard gold
timeFrame: Day one
Other outcomes:
Locations:
city: Paris
country: France
facility: CIC - Hôpital Européen Georges Pompidou
Study officials:
affiliation: Hôpital Européen Georges-Pompidou
name: Emmanuel Messas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Européen Georges-Pompidou
name: Anne Blanchard, MD
role: STUDY_CHAIR
affiliation: Hôpital Européen Georges-Pompidou
name: Joseph Emmerich, MD, PhD
role: STUDY_CHAIR
affiliation: Hôpital Européen Georges-Pompidou
name: Xavier Jeunemaitre, MD, PhD
role: STUDY_CHAIR
affiliation: Hôpital Européen Georges-Pompidou
name: Michael Franck, MD
role: STUDY_CHAIR
affiliation: Hôpital Européen Georges-Pompidou
name: Olivier Steinchen, MD
role: STUDY_CHAIR
affiliation: Hôpital Européen Georges-Pompidou
name: Michel Azizi, MD, PhD
role: STUDY_CHAIR
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