Non-Invasive Quantitative Imaging of Human Local Arterial Wall Elasticity Using Supersonic Shear … (NCT01096264) | Clinical Trial Compass
CompletedNot Applicable
Non-Invasive Quantitative Imaging of Human Local Arterial Wall Elasticity Using Supersonic Shear Imaging
France145 participantsStarted 2010-03
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.