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

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ClinicalTrials.gov Identifier: NCT03596437
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE May 29, 2018
First Posted Date  ICMJE July 23, 2018
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE January 7, 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
Agreement between ultrahigh-frequency and standard ultrasound in the identification of "triple signal" in the common carotid artery wall in fibromuscular dysplasia [ Time Frame: through study completion (an average of 30 minutes) ]
Triple signal is defined as the visual identification of supernumerary acoustic interface in the common carotid artery wall; K statistics will be used.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
  • Agreement between ultrahigh frequency and standard ultrasound in the evaluation of carotid intima-media thickness in fibromuscular dysplasia. [ Time Frame: 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. [ Time Frame: through study completion (an average of 30 minutes) ]
  • Agreement between ultrahigh frequency and standard ultrasound in the evaluation of carotid distensibility in fibromuscular dysplasia. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: through study completion (an average of 30 minutes) ]
    Intraclass coefficient, correlation at will be used
  • Reproducibility of radial distensibility, measured by ultrahigh frequency ultrasound in fibromuscular dysplasia and vascular Ehlers-Danlos syndrome. [ Time Frame: through study completion (an average of 30 minutes) ]
    Intraclass coefficient, correlation at will be used
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Arterial Properties by Ultra-high Frequency Ultrasound in Fibromuscular Dysplasia and Vascular Ehlers-Danlos Syndrome
Official Title  ICMJE Study of Arterial Properties by Ultra-high Frequency Ultrasound in Fibromuscular Dysplasia and Vascular Ehlers-Danlos Syndrome
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.

Detailed Description

Background: Fibromuscular dysplasia (FMD) is an idiopathic, systemic, non-atherosclerotic, non-inflammatory vascular disease leading to stenosis, aneurysms, dissections and occlusion of small and medium-sized arteries, with possible life-threatening complications. Recent data suggest that FMD is not so rare as previously thought, showing a prevalence up to 4%, but it is mostly undiagnosed. FMD mainly involves renal and internal carotid arteries, thus its clinical manifestations include hypertension and stroke. However, increasing evidence from large registries point out that FMD is a systemic disease, with a very high prevalence of multiple districts involvement.

Vascular Ehlers Danlos Syndrome (V-EDS) is a rare vascular disease (prevalence 1/150000), due to heterozygous mutations of COL3A1 gene, coding for collagen tipe III, with dominant autosomic transmission. V-EDS patients are predisposed to spontaneous ruptures in the vascular, intestinal districts and in many others.

In FMD, vascular subclinical alterations may be observed in usually usually not affected arterial districts, such as the common carotid artery and the radial artery. In a previous experience, Boutouyrie and colleagues discovered a peculiar phenotype in the common carotid artery of individuals with renal FMD. This pattern, known as "triple signal", is characterized by a supernumerary acoustic interface, located between the blood-intima and the media- adventitia interfaces and detected by either the B-mode or the radiofrequency equipment, which may correspond to medial hyperplasia. The "triple signal" pattern, though present in a small proportion of hypertensive patients, was able to accurately discriminate FMD individuals and in particular to identify familiar cases. Furthermore, c-IMT was higher in FMD, while diameter and elasticity were superimposable to hypertensive control group.

Nevertheless, the study of non-affected and easily accessible medium and small-sized arteries, such as the radial artery, with similar diameter and histology of affected arteries such as the renal, cerebral and coronary arteries, might be even more informative in FMD. This has been recently made possible by the commercial availability of ultra-high frequency ultrasound for human use. The machine is equipped with transducers up to 70 MHz and allows imaging superficial tissues with a spatial resolution up to 30 μm (axial) and 65 μm (lateral). Preliminary results by using ultrahigh frequency ultrasound, confirmed an increased radial wall thickness in FMD patients in comparison to age-, sex- and BP-matched controls. Most strikingly, wall ultrastructure was extensively subverted in FMD patients: the two echogenic layers corresponding to the elastic laminae presented a lower echogenicity and a greater inhomogeneity as compared to healthy individuals.

Methods: This is a cross-sectional study, recruiting 60 individuals with FMD and 30 individuals with V-EDS. Patients will be recruited by the Clinical Pharmacology Unit of the Hopital Europeen George Pompidou, during their routine visit for the ultrasound evaluation of the carotid arteries by echotracking. In that occasion, supplementary images of carotid, radial and digital arteries will be acquired by ultrahigh frequency ultrasound (VevoMD; Fujifilm-Visualsonics: Toronto, Canada).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Ehlers-Danlos Syndrome
  • Fibromuscular Dysplasia
Intervention  ICMJE Device: Ultra High Frequency ultrasound system
Agreement for carotid intima-media thickness in vascular Ehlers Danlos Syndrome and for triple signal identification in fibromuscular dysplasia will be assessed.
Other Name: Vevo MD
Study Arms  ICMJE
  • Experimental: Ehlers-Danlos Syndrome
    Intima-media thickness by ultrahigh frequency vs standard ultrasound
    Intervention: Device: Ultra High Frequency ultrasound system
  • Experimental: Fibromuscular Dysplasia
    Triple signal by ultrahigh frequency vs standard ultrasound
    Intervention: Device: Ultra High Frequency ultrasound system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 20, 2018)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pierre BOUTOUYRIE, PU-PH +33 1 5609 3991 pierre.boutouyrie@aphp.fr
Contact: Hakim KHETTAB +33 1 5609 2943 hakim.khettab@aphp.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03596437
Other Study ID Numbers  ICMJE P180201J
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Institut National de la Santé Et de la Recherche Médicale, France
Investigators  ICMJE Not Provided
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP