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

Establishment of Local Arterial Stiffness Normal Values (Carotid and Femoral) on Healthy Volunteers 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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Vascular Ehlers Danlos Syndrome
• Intervention / Treatment: Other: SSI and SphygmoCor® evaluations

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • CIC - Hôpital Européen Georges Pompidou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: NON_RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Healthy volunteer; Healthy volunteer undergoing two imagery evaluation : SSI technique for local PWV and arterial stiffness evaluation; SphygmoCor® for aortic PWV.	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.
OTHER: vEDS patients; vEDS patients undergoing two imagery evaluations: SSI technique for local PWV and arterial stiffness evaluation; SphygmoCor® for aortic PWV.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normal Values by SSI	Normal Values by SSI of local PWV and arterial wall stiffness(carotid and femoral).	day one

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: French Cardiology Society
• Collaborators: National Research Agency, France; Société Française de Médecine Vasculaire
• Investigators: Study Chair: Anne Blanchard, MD, Hopital Europeen Georges-Pompidou; Study Chair: Joseph Emmerich, MD, PhD, Hopital Europeen Georges-Pompidou; Study Chair: Xavier Jeunemaitre, MD, PhD, Hopital Europeen Georges-Pompidou; Study Chair: Michael Franck, MD, Hopital Europeen Georges-Pompidou; Study Chair: Olivier Steinchen, MD, Hopital Europeen Georges-Pompidou; Study Chair: Michel Azizi, MD, PhD, Hopital Europeen Georges-Pompidou

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: March 19, 2010
• First Submitted That Met QC Criteria: March 30, 2010
• First Posted (ESTIMATE): March 31, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): March 9, 2015
• Last Update Submitted That Met QC Criteria: March 6, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Arterial stiffness; Pulse wave velocity; Ultrafastecho; Supersonic shear imaging
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Congenital Abnormalities; Hematologic Diseases; Hemorrhagic Disorders; Genetic Diseases, Inborn; Connective Tissue Diseases; Hemostatic Disorders; Skin Diseases, Genetic; Skin Abnormalities; Collagen Diseases; Ehlers-Danlos Syndrome
• Other Study ID Numbers: 2009-03