Healthy Volunteers, Vascular Ehlers Danlos Syndrome
Conditions
Keywords
Arterial stiffness, Pulse wave velocity, Ultrafastecho, Supersonic shear imaging
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.
Interventions
OTHERSSI and SphygmoCor® evaluations
* 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.
Sponsors
National Research Agency, France
SOCIETE FRANCAISE DE MEDECINE VASCULAIRE
French Cardiology Society
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Normal Values by SSI | day one | Normal Values by SSI of local PWV and arterial wall stiffness(carotid and femoral). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 between 2 populations of values by SSI | Day one | Comparison between healthy volunteers and vEDS patients for PWV and arterial stiffness evaluated by SSI. |
| 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® |
Countries
France
Outcome results
None listed