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

NCT ID: NCT01096264

Last Updated: 2015-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-03-31

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.

Detailed Description

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

Conditions

Healthy Volunteers; Vascular Ehlers Danlos Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Blinding Strategy: NONE

Study Groups

Healthy volunteer

Healthy volunteer undergoing two imagery evaluation :

• SSI technique for local PWV and arterial stiffness evaluation
• SphygmoCor® for aortic PWV.

Group Type: OTHER

SSI and SphygmoCor® evaluations

Intervention Type: 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.

vEDS patients

vEDS patients undergoing two imagery evaluations:

• SSI technique for local PWV and arterial stiffness evaluation
• SphygmoCor® for aortic PWV.

Group Type: OTHER

SSI and SphygmoCor® evaluations

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

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

• 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.

• No intact (carotid or femoral) segment for SSI analysis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Research Agency, France

OTHER

Sponsor Role: collaborator

SOCIETE FRANCAISE DE MEDECINE VASCULAIRE

UNKNOWN

Sponsor Role: collaborator

French Cardiology Society

OTHER

Sponsor Role: lead

Responsible Party

Hôpital Européen Georges Pompidou

Principal Investigators

Emmanuel Messas, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Européen Georges-Pompidou

Anne Blanchard, MD

Role: STUDY_CHAIR

Hôpital Européen Georges-Pompidou

Joseph Emmerich, MD, PhD

Role: STUDY_CHAIR

Hôpital Européen Georges-Pompidou

Xavier Jeunemaitre, MD, PhD

Role: STUDY_CHAIR

Hôpital Européen Georges-Pompidou

Michael Franck, MD

Role: STUDY_CHAIR

Hôpital Européen Georges-Pompidou

Olivier Steinchen, MD

Role: STUDY_CHAIR

Hôpital Européen Georges-Pompidou

Michel Azizi, MD, PhD

Role: STUDY_CHAIR

Hôpital Européen Georges-Pompidou

Locations

CIC - Hôpital Européen Georges Pompidou

Paris, , France

Countries

France

Other Identifiers

2009-03

Identifier Type: -

Identifier Source: org_study_id