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

French Cardiology Society

Status: Completed

Conditions: Healthy Volunteers; Vascular Ehlers Danlos Syndrome

Treatments: Other: SSI and SphygmoCor® evaluations

Study type: Interventional

Funder types: Other

Identifiers

NCT01096264

2009-03

Details and patient eligibility

About

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.

Full description

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

Enrollment: 145 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

145 participants in 2 patient groups

Healthy volunteer

Other group

Description:

Healthy volunteer undergoing two imagery evaluation : * SSI technique for local PWV and arterial stiffness evaluation * SphygmoCor® for aortic PWV.

Treatment:

Other: SSI and SphygmoCor® evaluations

vEDS patients

Other group

Description:

vEDS patients undergoing two imagery evaluations: * SSI technique for local PWV and arterial stiffness evaluation * SphygmoCor® for aortic PWV.

Treatment:

Other: SSI and SphygmoCor® evaluations