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Идёт набор NCT06004154

Post-therapeutic Imaging Evaluation of Patients With Horton's Disease (Giant Cell Arteritis) (EvHortim)

— Наблюдательное Giant Cell Arteritis

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: Injected cerebral MRI angiography and ultrasound of the superior aortic trunks, temporal and axillary arteries.
Кому может быть актуально
Состояния в реестре: Giant Cell Arteritis. 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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Официальное название

Post-therapeutic Imaging Evaluation of Patients With Horton's Disease (Giant Cell Arteritis)

Обзор

Giant cell arteritis (GCA), also known as Horton's disease, is an inflammatory arteritis of the large and medium-sized arteries, with an estimated incidence of 17.8/100,000 in people over 50. The disease presents potential ophthalmological, neurological, cardiac and aortic vascular complications, making diagnosis an emergency in cases of suspected Horton's disease. only corticosteroid therapy started as early as possible can prevent these complications. Diagnosis has historically relied on temporal artery biopsy, but the recent ACR/EULAR 2022 classification criteria propose alternatives to this invasive examination, in particular imaging tests such as temporal artery ultrasound and PET scans. Although not included in these latest recommendations, high-definition wall MRI can also provide arguments in favor of this diagnosis, and avoid the need for a temporal artery biopsy, the sensitivity of which is only 75%. The investigators recently demonstrated in a prospective cohort that wall MRI, possibly coupled with temporal artery ultrasound or retinal angiography, was far superior to temporal artery biopsy in diagnostic performance. The main limitation of these imaging tests is the lack of data in the literature on the evolution of abnormalities over time, and in particular after initiation of oral corticosteroid therapy. This uncertainty makes it difficult to use these examinations to monitor disease activity, particularly in cases of suspected relapse, a frequent situation in which the clinician is regularly put at fault due to an often frustrating symptomatology and the possible absence of a frank biological inflammatory syndrome. The investigators propose to conduct a study aimed at describing the evolution of cranial vessel wall abnormalities on wall MRI and ultrasound by systematically repeating these examinations at 1 month, 3 months from the initial MRI performed at diagnosis, in addition to the follow-up performed as part of care at 6 and 12 months from diagnosis. In the event of a relapse in the intervening period, a new MRI scan can be performed and compared with the most recent MRI scan, to look for evidence of disease activity.

Вмешательства

  • Диагностический тест Injected cerebral MRI angiography and ultrasound of the superior aortic trunks, temporal and axillary arteries
    Injected cerebral MRI angiography and ultrasound of the superior aortic trunks, temporal and axillary arteries added to the usual follow-up at 1, 3, 6 and 12 months

Первичные конечные точки

  • Describe the evolution over time of angiographic-MRI abnormalities at 1 month, 3 months, 6 and 12 months from the diagnosis of Horton's disease. [Срок оценки: Day0 to Month12]
  • Describe the evolution over time of ultrasound abnormalities at 1 month, 3 months, 6 and 12 months from the diagnosis of Horton's disease. [Срок оценки: Day0 to Month12]
  • Describe the evolution over time of ultrasound abnormalities at 1 month, 3 months, 6 and 12 months from the diagnosis of Horton's disease. [Срок оценки: Day0 to Month12]
  • Describe the evolution over time of ultrasound abnormalities at 1 month, 3 months, 6 and 12 months from the diagnosis of Horton's disease. [Срок оценки: Day0 to Month12]

Критерии участия

Критерии включения

  • Patient aged 50 and over
  • Having received informed consent to participate in the study
  • Affiliated or beneficiary of a social insurance scheme
  • Patients with giant cell arteritis according to ACR/EULAR 2022 criteria
  • Diagnosed with MRI and ultrasound.

Критерии исключения

  • Absolute or relative contraindication to MRI (incompatible implantable device, claustrophobia, etc.)
  • Hypersensitivity to gadobutrol
  • Patient under legal protection
  • Pregnant or breast-feeding women

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Hopital Fondation Adolphe de Rothschild — Paris

Идентификаторы

NCT: NCT06004154 · GCL_2023_3

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗