Study of Arterial Properties by Ultra-high Frequency Ultrasound in Fibromuscular Dysplasia and Vascular Ehlers-Danlos Syndrome

NCT03596437 | Unknown

• 1 other identifier: P180201J
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ehlers-Danlos Syndrome; Fibromuscular Dysplasia

Keywords

Fibromuscular dysplasia; Vascular Ehler-Danlos Syndrome; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Agreement between ultrahigh-frequency and standard ultrasound in the identification of "triple signal" in the common carotid artery wall in fibromuscular dysplasia

  Triple signal is defined as the visual identification of supernumerary acoustic interface in the common carotid artery wall; K statistics will be used.

  through study completion (an average of 30 minutes)

Secondary Outcomes (6)

• Agreement between ultrahigh frequency and standard ultrasound in the evaluation of carotid intima-media thickness in fibromuscular dysplasia.

  through study completion (an average of 30 minutes)

• Agreement between ultrahigh frequency and standard ultrasound in the evaluation of carotid intima-media thickness in vascular Ehlers-Danlos syndrome.

  through study completion (an average of 30 minutes)

• Agreement between ultrahigh frequency and standard ultrasound in the evaluation of carotid distensibility in fibromuscular dysplasia.

  through study completion (an average of 30 minutes)

• Agreement between ultrahigh frequency and standard ultrasound in the evaluation of carotid distensibility in vascular Ehlers-Danlos syndrome.

  through study completion (an average of 30 minutes)

• Reproducibility of radial intima-media thickness, measured by ultrahigh frequency ultrasound in fibromuscular dysplasia and vascular Ehlers-Danlos syndrome.

  through study completion (an average of 30 minutes)

Study Arms (2)

Ehlers-Danlos Syndrome

EXPERIMENTAL

Intima-media thickness by ultrahigh frequency vs standard ultrasound

Device: Ultra High Frequency ultrasound system

Fibromuscular Dysplasia

EXPERIMENTAL

Triple signal by ultrahigh frequency vs standard ultrasound

Device: Ultra High Frequency ultrasound system

Interventions

Ultra High Frequency ultrasound system DEVICE

Agreement for carotid intima-media thickness in vascular Ehlers Danlos Syndrome and for triple signal identification in fibromuscular dysplasia will be assessed.

Also known as: Vevo MD

Ehlers-Danlos Syndrome; Fibromuscular Dysplasia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Persons referred to in Articles L. 1121-5 to L. 1121-8 and L. 1122-12 of the Public Health Code
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Unité de pharmacologie clinique HEGP

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Ehlers-Danlos Syndrome; Fibromuscular Dysplasia

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; 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; Arterial Occlusive Diseases

Central Study Contacts

Pierre BOUTOUYRIE, PU-PH

CONTACT

+33 1 5609 3991; pierre.boutouyrie@aphp.fr

Hakim KHETTAB

CONTACT

+33 1 5609 2943; hakim.khettab@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: July 23, 2018
• Study Start: January 7, 2019
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)