CompletedNot Applicable

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

France145 participantsStarted 2010-03

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. …

What they're measuring

Normal Values by SSI

Timeframe: day one

Trial details

NCT IDNCT01096264

SponsorFrench Cardiology Society

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-03