An interventional study of SSI and SphygmoCor® evaluations in Healthy Volunteers and Vascular Ehlers Danlos Syndrome, sponsored by French Cardiology Society. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-09.
Sponsored by French Cardiology Society · Not applicable and Interventional
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.
Provide a more extensive description, if desired. Avoid duplication of information to be recorded elsewhere, such as eligibility criteria or outcome measures.
75 studies on the registry are indexed under Ehlers-Danlos Syndrome; 25 are open to participants now.
This study's enrollment of 145 is above the median of 52 across 42 interventional studies indexed under Ehlers-Danlos Syndrome.
Browse Ehlers-Danlos Syndrome studies →French Cardiology Society is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for Healthy Volunteers
Inclusion criteria for patient :
General Exclusion Criteria :
Exclusion criteria for Healthy volunteers
Exclusion criteria for Patients
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 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.
Normal Values by SSI
Normal Values by SSI of local PWV and arterial wall stiffness(carotid and femoral).
Time frame: day one
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).
Time frame: 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.
Time frame: 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®
Time frame: Day one
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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French Cardiology Society