Меню
Набор скоро начнётся NCT07508514

Early Temporal Dynamics of Optic Nerve Sheath Diameter After Therapy in GCA

— Наблюдательное Giant Cell Arteritis Temporal Arteritis Optic Nerve Diseases Diagnosis

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: Optic Nerve Sheath Ultrasound, Temporal artery ultrasound, Bloodwork : CRP and ESR.
Кому может быть актуально
Состояния в реестре: Giant Cell Arteritis, Temporal Arteritis, Optic Nerve Diseases, Diagnosis. 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Early Temporal Dynamics of Optic Nerve Sheath Diameter After Glucocorticoid Therapy in Giant Cell Arteritis

Обзор

Giant cell arteritis (GCA) is an inflammatory disease of large and medium arteries that can cause irreversible vision loss. Glucocorticoids (GCs) rapidly suppress inflammation, but diagnostic imaging tests such as temporal artery ultrasound or biopsy often become falsely negative within days of treatment. The optic nerve sheath diameter (ONSD), measurable by ocular ultrasound, reflects perineural edema and may serve as a quantitative biomarker of ocular inflammation in GCA. The SONIC-TIME study (Early Temporal Dynamics of Optic Nerve Sheath Diameter After Glucocorticoid Therapy in Giant Cell Arteritis) is a single-center, prospective observational substudy embedded within SONIC-GCA (NCT05749094) at Hôpital du Sacré-Cœur de Montréal. It aims to characterize how rapidly ONSD decreases after GC initiation and how this trajectory relates to cumulative GC exposure, intravenous methylprednisolone, and early use of steroid-sparing therapies. Sixty participants with newly diagnosed GCA will undergo serial optic nerve sheath ultrasound, blood tests (CRP, ESR), and when feasible, temporal artery ultrasound over the first two months of therapy (Days 3, 7, 10, 14, 21, 28, and Month 2). No experimental treatments are given; all participants receive standard-of-care therapy. The primary objective is to quantify the percent change in mean ONSD from baseline to Day 28. Secondary objectives include modeling ONSD change over time, assessing associations with cumulative steroid dose and inflammatory markers, and estimating the time to normalization below the SONIC-GCA cutoff. Findings will define the optimal imaging window and refine the diagnostic and monitoring role of optic nerve ultrasound in GCA.

Вмешательства

  • Диагностический тест Optic Nerve Sheath Ultrasound
    Optic nerve sheath ultrasound will be performed in combination with a digital retinal fundoscopy.
  • Диагностический тест Temporal artery ultrasound
    With measurement of the intima-media complex and calculation of the OGUS.
  • Диагностический тест Bloodwork : CRP and ESR
    At each visit

Первичные конечные точки

  • Change in mean ONSD (in mm) from day 0 to day 28 [Срок оценки: Day 28]
Вторичные конечные точки (10)
  • Change in mean ONSD (in mm, using ultrasound) from day 0 to day 14 [Срок оценки: Day 14]
  • Change in mean ONSD (in mm, using ultrasound) from day 0 to month 2 [Срок оценки: Month 2]
  • Association between cumulative glucocorticoids (GCs, in mg) and ONSD (in mm, by ultrasound) [Срок оценки: Month 2]
  • Association between IV methylprednisolone (binary : yes or no) and ONSD (in mm, by ultrasound) [Срок оценки: Month 2]
  • Association between immunosuppressive therapy (categorical, documented using medication list) and ONSD (in mm, by ultrasound) [Срок оценки: Month 2]
  • ONSD threshold (from the SONIC-GCA trial) performance over time [Срок оценки: Month 2]
  • Time (in days) to ONSD normalization [Срок оценки: Month 2]
  • Association between inflammatory markers and ONSD [Срок оценки: Month 2]
  • Association between OGUS and ONSD [Срок оценки: Month 2]
  • Association between digital retinal fundoscopy and ONSD (in mm, by ultrasound) [Срок оценки: Month 2]

Критерии участия

Критерии включения

  • Participants must be enrolled in SONIC-GCA and must have:
  • completed the baseline optic nerve sheath ultrasound
  • confirmed GCA as determined by the baseline standardized GCA assessment in SONIC-GCA.
  • Exposure to glucocorticoids for ≤ 48 hours and ≤ 160 mg prednisone-equivalent before baseline.
  • Ability and willingness to provide written informed consent.
  • Agreement to complete the SONIC-TIME intensive follow-up schedule.

Критерии исключения

1\) Concurrent participation in a blinded interventional pharmaceutical clinical trial.

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 1 центр
  • Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal — Montreal

Идентификаторы

NCT: NCT07508514 · 2026-3095

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗