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NCT Number: NCT01096264

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SSI and SphygmoCor® evaluations

Other
  • 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.

Primary outcomes

  1. Normal Values by SSI

    Time frame: day one

    Normal Values by SSI of local PWV and arterial wall stiffness(carotid and femoral).

Secondary outcomes

  1. repeatability of the "primary outcome measure"

    Time frame: Day one

    Evaluation of the repeatability of the "primary outcome measure" on 100 healthy volunteers and 30 patients with Vascular Ehlers Danlos Syndrome (vEDS).

  2. Comparison between 2 populations of values by SSI

    Time frame: Day one

    Comparison between healthy volunteers and vEDS patients for PWV and arterial stiffness evaluated by SSI.

  3. Comparison of values between SSI and standard gold

    Time frame: Day one

    Concordance evaluation between PWV calculated by SSI and Aortic Pulse wave velocity calculated by ShygmoCor®

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Collaborators

  • National Research Agency, France
  • SOCIETE FRANCAISE DE MEDECINE VASCULAIRE

Registry information

Official study title

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

Acronym: ULTRAFASTECHO

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 31, 2010
Registry last updated
Mar 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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