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

Healthy Volunteers Clinical Trial

— ULTRAFASTECHO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096264
• Other study ID #: 2009-03
• Status: Completed
• Phase: N/A
• First received: March 19, 2010
• Last updated: March 6, 2015
• Start date: March 2010
• Est. completion date: March 2011

Study information

• Verified date: March 2015
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Ehlers-Danlos Syndrome
• Healthy Volunteers
• Vascular Ehlers Danlos Syndrome

Intervention

Other:
• SSI 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.

Locations

Country	Name	City	State
France	CIC - Hôpital Européen Georges Pompidou	Paris

Sponsors (3)

Lead Sponsor	Collaborator
French Cardiology Society	National Research Agency, France, SOCIETE FRANCAISE DE MEDECINE VASCULAIRE

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normal Values by SSI	Normal Values by SSI of local PWV and arterial wall stiffness(carotid and femoral).	day one	No
Secondary	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	No
Secondary	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	No
Secondary	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	No