- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT06336083
Familjär form av carotisweb: en Doppler-ultraljudsstudie (Family-WEB)
Familjescreening för inre carotis diaphragm dysplasia (carotid WEB): en Doppler-ultraljudsstudie
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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Louis FONTAINE, MD
- Telefonnummer: +33 05 61 77 93 67
- E-post: fontaine.l@chu-toulouse.fr
Studieorter
-
-
-
Toulouse, Frankrike, 31059
- Rekrytering
- CHU de Toulouse, Purpan
-
Kontakt:
- Louis FONTAINE, MD
- Telefonnummer: +33 05 61 77 93 67
- E-post: fontaine.l@chu-toulouse.fr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Doppler ultrasound
First degree relatives of patient with diagnosed carotid web will receive an echography doppler of the carotid arteries and answer questionnaires |
Participants will receive doppler ultrasound of the carotid arteries, and no other interventions studied |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evaluation of the prevalence of carotid web by doppler ultrasound in first-degree relatives of patients with carotid web.
Tidsram: Inclusion day
|
Number of first-degree relatives with at least one carotid web on doppler ultrasound. |
Inclusion day
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Description of the clinical characteristics of relatives with carotid web and their index case.
Tidsram: Inclusion day
|
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.
Tidsram: Inclusion day
|
Morphological characteristics on doppler ultrasound of the carotid web in relatives and in index cases: length, width, echogenicity, hemodynamic impact. |
Inclusion day
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Claire VILLEPINTE, MD, University Hospital, Toulouse
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- RC31/23/0618
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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