Study of Arterial Properties by Ultra-high Frequency Ultrasound in Fibromuscular Dysplasia and Va… (NCT03596437) | Clinical Trial Compass
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Study of Arterial Properties by Ultra-high Frequency Ultrasound in Fibromuscular Dysplasia and Vascular Ehlers-Danlos Syndrome
France90 participantsStarted 2019-01-07
Plain-language summary
Ultra-high frequency ultrasound may be useful in the field of vascular research, given its ability to accurately characterize arterial wall thickness and ultrastructure.
In patients with fibromuscular dysplasia (FMD), it may help identify the "triple signal" pattern in carotid arterial wall, while in Vascular Ehlers Danlos Syndrome (V-EDS) it may help to accurately measure carotid intima-media thickness, which may be extremely small and difficult to measure with standard equipment. Furthermore, novel features might be identified in small-to-medium sized arteries by ultra-high frequency ultrasound.
The main aim of this study is to demonstrate that ultra-high frequency ultrasound has the same accuracy of standard ultrasound for the identification of "triple signal" in the carotid artery of FMD.
Secondary aims of this study are to evaluate carotid, radial and digital intima-media thickness, wall ultrastructure and distensibility in 60 patients with FMD and in 30 patients with V-EDS.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for patients with FMD:
* Patients aged between 18 and 80 inclusive
* Patients who have already been diagnosed with FMD of the renal arteries, cervical or cerebral arteries or spontaneous coronary dissections
* Informed consent signed,
* Patient affiliated to a social security.
Inclusion Criteria for patients with Ehlers-Danlos vascular syndrome:
* Patients aged between 18 and 80 inclusive
* Patients with a previous diagnosis of vascular Ehlers-Danlos vascular syndrome
* Informed consent signed,
* Patient affiliated to a social security.
Exclusion Criteria:
* Persons referred to in Articles L. 1121-5 to L. 1121-8 and L. 1122-12 of the Public Health Code
* Person subject to an exclusion period for another research
* Pregnancy in progress
* Allergies to ultrasound gel or skin lesions (severe eczema, wounds, etc.) that prevent the echo probe from being applied to the area of interest.
* Refusal or inability to read information, to sign informed consent and not to oppose research, linguistically or psychologically
* Severe life-threatening disease in the short to medium term
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.
What they're measuring
1
Agreement between ultrahigh-frequency and standard ultrasound in the identification of "triple signal" in the common carotid artery wall in fibromuscular dysplasia
Timeframe: through study completion (an average of 30 minutes)