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

NCT01096264 | Completed

• 1 other identifier: 2009-03
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers; Vascular Ehlers Danlos Syndrome

Keywords

Arterial stiffness; Pulse wave velocity; Ultrafastecho; Supersonic shear imaging

Outcome Measures

Primary Outcomes (1)

• Normal Values by SSI

  Normal Values by SSI of local PWV and arterial wall stiffness(carotid and femoral).

  day one

Secondary Outcomes (3)

• repeatability of the "primary outcome measure"

  Day one

• Comparison between 2 populations of values by SSI

  Day one

• Comparison of values between SSI and standard gold

  Day one

Study Arms (2)

Healthy volunteer

OTHER

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

Other: SSI and SphygmoCor® evaluations

vEDS patients

OTHER

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

Other: SSI and SphygmoCor® evaluations

Interventions

SSI and SphygmoCor® evaluations OTHER

* 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.

Healthy volunteer; vEDS patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Pregnancy
• Echograph gel allergy
• Local Artery disease (dissection or thrombosis)
• Arrhythmia
• No health insurance coverage
• Incapacity or refused to sign the consent form
• Acute or Chronic Systemic disease (atherosclerosis)
• Alcohol abuse or drug abuse (cocaine,cannabis,etc..)
• Active or past tobacco
• Hypercholesterolemia (LDLc \>1.09 g/l)
• No intact (carotid or femoral) segment for SSI analysis

Sponsors & Collaborators

• French Cardiology Society: lead
• National Research Agency, France: collaborator
• SOCIETE FRANCAISE DE MEDECINE VASCULAIRE: collaborator

Study Sites (1)

CIC - Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

MeSH Terms

Conditions

Ehlers-Danlos Syndrome, Type IV

Condition Hierarchy (Ancestors)

Aortic Dissection; Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Ehlers-Danlos Syndrome; Hemostatic Disorders; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Emmanuel Messas, MD

  Hôpital Européen Georges-Pompidou

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 19, 2010
• First Posted: March 31, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 9, 2015

Record last verified: 2015-03

Locations

FR (1)