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

This study has been completed.
Sponsor:
Collaborators:
AGENCE NATIONALE DE RECHERCHE
SOCIETE FRANCAISE DE MEDECINE VASCULAIRE
Information provided by:
French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01096264
First received: March 19, 2010
Last updated: March 22, 2011
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention
Healthy Volunteers
Vascular Ehlers Danlos Syndrome
 Other: SSI and SphygmoCor® evaluations

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Establishment of Local Arterial Stiffness Normal Values (Carotid and Femoral) on Healthy Volunteers Using Supersonic Shear Imaging

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • Normal Values by SSI [ Time Frame: day one ] [ Designated as safety issue: No ]
    Normal Values by SSI of local PWV and arterial wall stiffness(carotid and femoral).


Secondary Outcome Measures:
  • repeatability of the "primary outcome measure" [ Time Frame: Day one ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day one ] [ Designated as safety issue: No ]
    Comparison between healthy volunteers and vEDS patients for PWV and arterial stiffness evaluated by SSI.

  • Comparison of values between SSI and standard gold [ Time Frame: Day one ] [ Designated as safety issue: No ]
    Concordance evaluation between PWV calculated by SSI and Aortic Pulse wave velocity calculated by ShygmoCor®


Estimated Enrollment: 145
Study Start Date: March 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096264

Locations
France
CIC - Hôpital Européen Georges Pompidou
Paris, France, 75015
Sponsors and Collaborators
French Cardiology Society
AGENCE NATIONALE DE RECHERCHE
SOCIETE FRANCAISE DE MEDECINE VASCULAIRE
Investigators
Principal Investigator: Emmanuel Messas, MD Hôpital Européen Georges Pompidou
Study Chair: Anne Blanchard, MD Hôpital Européen Georges Pompidou
Study Chair: Joseph Emmerich, MD, PhD Hôpital Européen Georges Pompidou
Study Chair: Xavier Jeunemaitre, MD, PhD Hôpital Européen Georges Pompidou
Study Chair: Michael Franck, MD Hôpital Européen Georges Pompidou
Study Chair: Olivier Steinchen, MD Hôpital Européen Georges Pompidou
Study Chair: Michel Azizi, MD, PhD Hôpital Européen Georges Pompidou
  More Information

No publications provided

Responsible Party: Dr Emmanuel Messas, Hôpital Européen Georges Pompidou
ClinicalTrials.gov Identifier: NCT01096264     History of Changes
Other Study ID Numbers: 2009-03
Study First Received: March 19, 2010
Last Updated: March 22, 2011
Health Authority: France: Ministry of Health

Keywords provided by French Cardiology Society:
Arterial stiffness
Pulse wave velocity
Ultrafastecho
Supersonic shear imaging

Additional relevant MeSH terms:
Ehlers-Danlos Syndrome
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
 Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 17, 2013