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

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

Official Title
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Establishment of Local Arterial Stiffness Normal Values (Carotid and Femoral) on Healthy Volunteers Using Supersonic Shear Imaging

Conditions
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Healthy Volunteers, Vascular Ehlers Danlos Syndrome

Intervention / Treatment
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* Other: SSI and SphygmoCor® evaluations


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy volunteer<br>Healthy volunteer undergoing two imagery evaluation : SSI technique for local PWV and arterial stiffness evaluation SphygmoCor® for aortic PWV. | Other: SSI and SphygmoCor® evaluations<br>* SSI evaluation need Aixplorer vascular ultrasound machine (available in our department) with 8 MHz linear array probe applied on the carotid and femoral artery. SphygmoCor® evaluation used pressure captors on carotid and femoral sites to record the intra-arterial pressure wave time delay after QRS wave. After distance calculation between the two sites, Aortic PWV can be derived.<br>|
| Other: vEDS patients<br>vEDS patients undergoing two imagery evaluations: SSI technique for local PWV and arterial stiffness evaluation SphygmoCor® for aortic PWV. | Other: SSI and SphygmoCor® evaluations<br>* SSI evaluation need Aixplorer vascular ultrasound machine (available in our department) with 8 MHz linear array probe applied on the carotid and femoral artery. SphygmoCor® evaluation used pressure captors on carotid and femoral sites to record the intra-arterial pressure wave time delay after QRS wave. After distance calculation between the two sites, Aortic PWV can be derived.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal Values by SSI | Normal Values by SSI of local PWV and arterial wall stiffness(carotid and femoral). | day one | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arterial stiffness, Pulse wave velocity, Ultrafastecho, Supersonic shear imaging