Familial Form of Carotid Web: a Doppler Ultrasound Study (Family-WEB)

Family Screening for Internal Carotid Diaphragm Dysplasia (Carotid WEB): a Doppler Ultrasound Study

There is no evidence of familial forms of carotid web. The aim of this study is to determine the prevalence of carotid web among relatives of patient with carotid web using carotid doppler ultrasound.

Study Overview

• Status: Not yet recruiting
• Conditions: Carotid Web
• Intervention / Treatment: Procedure: Doppler ultrasound

Detailed Description

Carotid web are rare, focal dysplasia of the internal carotid artery and a high risk causes of stroke in young adult. Natural history of these dysplasia remains poorly understood. High prevalence of carotid web among Afro-Caribbean population and the similarity between carotid web and fibromuscular dysplasia, suggest existence of genetic factors. But there has been to our knowledge no familial form of carotid web reported. The aim of this study is to determine the prevalence of carotid web among relatives of patients with carotid web using carotid duplex doppler ultrasound.

Researchers aim to test whether carotid web could be detected in relatives of patients with known carotid web, using duplex doppler ultrasound.

This is a pilot, transversal, single-center study performed at Toulouse University Hospital, France. From 30 carotid web cases aged under 65 (patients with previously known Carotid web, symptomatic or not) followed in neurology department, investigators aim to include 60 first-degree relatives younger than 65 years old. Included relatives will underwent carotid duplex doppler ultrasound to detect carotid web. The primary outcome is the prevalence of carotid web among relatives. Secondary outcomes include : Number of families with at least one relative who has been diagnosed with carotid web, number of relatives who has been diagnosed with carotid web per family, clinical characteristics of patients and morphological characteristics of carotid web.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Louis FONTAINE, MD; Phone Number: +33 05 61 77 93 67; Email: fontaine.l@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31059
    • CHU de Toulouse, Purpan
    • Contact: Louis FONTAINE, MD; Phone Number: +33 05 61 77 93 67; Email: fontaine.l@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Carotid Web index patients:

• Patients with carotid web confirmed by CT angiogram (CTA) of cervical arteries or digital substraction angiogram (DSA).
• At least one first degree relative aged younger than 65 years old.

Relatives patients :

- First degree relatives of patient with diagnosed carotid web.

Exclusion Criteria:

• Persons placed under judicial protection or under another protection status
• Pregnant or breastfeeding woman.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Doppler ultrasound; First degree relatives of patient with diagnosed carotid web will receive an echography doppler of the carotid arteries and answer questionnaires	Procedure: Doppler ultrasound; Participants will receive doppler ultrasound of the carotid arteries, and no other interventions studied

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the prevalence of carotid web by doppler ultrasound in first-degree relatives of patients with carotid web.	Number of first-degree relatives with at least one carotid web on doppler ultrasound.	Inclusion day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the clinical characteristics of relatives with carotid web and their index case.	Clinical characteristics of relatives with a carotid web and index cases: age, sex, vascular risk factors, medical history, family history, current treatments, bilateral nature of the carotid web.	Inclusion day
Description of the morphological characteristics of relatives with carotid web and their index case.	Morphological characteristics on doppler ultrasound of the carotid web in relatives and in index cases: length, width, echogenicity, hemodynamic impact.	Inclusion day

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Claire VILLEPINTE, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: inheritance; carotid web; echography doppler
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Fibromuscular Dysplasia
• Other Study ID Numbers: RC31/23/0618

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No