oPtic Nerve Sheath Evaluation in gianT Cell aRtheritis by UltraSound
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: orbital ultrasound.
- Кому может быть актуально
- Состояния в реестре: Giant Cell Arteritis (GCA). Базовые параметры: от 50 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The purpose of this study is to evaluate whether the measure of the optic nerve sheath is a reliable diagnostic marker for giant cell arteritis
Подробное описание
Giant Cell Arteritis (GCA) is a vasculitis affecting large and medium-sized vessels. It predominantly occurs in women, with a sex ratio of 3:1, and mainly affects individuals around 70 years of age. GCA is a rare condition, with an incidence of approximately 10 cases per 100,000 people in France.
Current recommendations suggest using imaging techniques and/or temporal artery biopsy (TAB) based on the clinical resources available. The key challenge in suspected cases of GCA is to establish a rapid diagnosis.
It is important to note that false-negative imaging results may occur if corticosteroid treatment is initiated prior to imaging: after 3 days for PET-CT, 5 to 7 days for Doppler ultrasound, and up to 14 days for TAB.
Diagnosing GCA is not always easy and depends on depends on the prompt performance of complementary examinations. Studies have shown that the optic nerve sheath is thickened on ultrasound in patients with GCA. In this context, the investigator aims to evaluate the measurement of the optic nerve sheath via ultrasound for diagnosing GCA. Ultrasound offers a faster, non-invasive, widely available, and cost-effective diagnostic tool.
Вмешательства
- Диагностический тест orbital ultrasound
orbital ultrasound at the beginning of the participation, and at 6 months after the inclusion.
Первичные конечные точки
- Assess whether the Optic Nerve Sheath Diameter (ONSD) measured by orbital ultrasound serves as an effective diagnostic marker for Giant Cell Arteritis (GCA) [Срок оценки: At the patient enrollment visit and at 6 months]
Вторичные конечные точки (8)
- Assess the reproducibility of the optic nerve sheath diameter (ONSD) measurements by ultrasound. [Срок оценки: At the patient enrollment visit and at 6 months]
- Evaluate the diagnostic performance of ONSD in GCA. [Срок оценки: At the patient enrollment visit and at 6 months]
- Study the evolution of ONSD under treatment between M0 and M6 in patients with GCA. [Срок оценки: At the patient enrollment visit and at 6 months]
- Exploratory evaluation of ONSD according to the presence or absence of extracranial GCA. [Срок оценки: At the patient enrollment visit and at 6 months]
- Exploratory evaluation of ONSD based on the presence or absence of GCA with visual involvement. [Срок оценки: At the patient enrollment visit and at 6 months]
- Assess the feasibility of ultrasound as a diagnostic tool for GCA. [Срок оценки: At the patient enrollment visit and at 6 months]
- Assess the feasibility of ultrasound as a diagnostic tool for GCA. [Срок оценки: At the patient enrollment visit and at 6 months]
- Assess the feasibility of ultrasound as a diagnostic tool for GCA. [Срок оценки: At the patient enrollment visit and at 6 months]
Критерии участия
Критерии включения
- Patient with suspected GCA
- Patient over 50 years
Критерии исключения
- Patient with history of GCA
- Patient with a history of polymyalgia rheumatic (PMR) without initial PET scan
- Patient with a history of retinal disease, demyelinating disease, or intracranial hypertension
- Use of corticosteroids > 0.5mg/kg in the last 2 weeks
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Франция · 9 центров
- Rhumatology departement - Centre Hospitalier Aix en Provence — Aix-en-Provence
- Rhumatology department - Centre Hospitalier Universitaire de Brest — Brest
- Internal Medecine Department- CHU Caen — Caen
- Internal Medicine and Clinical Immulogy department - Centre Hospitalier Universitaire de D — Dijon
- Internal Medicine and VascularMedecine Department - Centre Hospitalier Universitaire de Na — Nantes
- Internal Medicine department - Hôpital Saint-Antoine — Paris
- Rhumatology department - Hôpital Bichat — Paris
- Rhumatology department - Hôpital NOVO - Pontoise site — Pontoise
- … и ещё 1 центр
Идентификаторы
NCT: NCT07001059 · CHRD 0524 · 2025-A00141-48