Optic Nerve Sheath Ultrasound in Giant Cell Arteritis

Официальное название

The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis

Обзор

The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis (SONIC-GCA) study will evaluate the performance of the optic nerve sheath diameter (ONSD), measured via ultrasound, to diagnose and monitor GCA. SONIC-GCA builds upon our previous pilot studies and will answer the following questions: 1. What is the performance of ONSD to identify patients with new-onset, active GCA? 2. Is ONSD useful for monitoring GCA relapses during follow-up? 3. What is the intra- and interobserver reliability of ONSD measurements? 4. Does ONSD differ between patients with and without GCA-related retinal findings?

Подробное описание

SONIC-GCA is a prospective cohort and validation study conducted in centers of the Canadian Vasculitis Research Network (CanVasc).

Вмешательства

• Диагностический тест Optic nerve sheath ultrasound
  The patients are examined in a supine relaxed position. The probe is gently placed on the closed eyelid with a standard ultrasound gel and adjusted to a suitable angle to display the optic nerve entry into the eyeball. Measurements are done 3mm distal to the posterior aspect of the ocular globe. Ultrasosonographic 14L5 probe is used with a safe thermal index, mechanical index and intensity limit. All patients will also undergo a bedside fundoscopic examination. Official ophthalmology consultatio
• Диагностический тест Standardized GCA assessment
  Clinical assesment, blood test review, temporal/axillary artery ultrasound

Первичные конечные точки

• Diagnostic performance of ONSD to identify new-onset GCA [Срок оценки: Baseline]
• ONSD in patients with and without GCA [Срок оценки: Baseline]

Вторичные конечные точки (3)

• ONSD changes over time [Срок оценки: Up to 2 years]
• The associations between ONSD changes and GCA relapses [Срок оценки: Up to 2 years]
• Evaluation of the performance of ONSD to detect a GCA relapse [Срок оценки: Up to 2 years]

Критерии участия

Our population of interest is patients referred from any settings for suspected, new-onset GCA.

Критерии включения

To be included in SONIC-GCA, participants must meet all the following criteria:

• Age > 50 years.
• Referral to a GCA clinic for suspected, new-onset GCA.
• Ability to understand and willingness to sign an informed consent form.
• Willingness to comply with study visits and procedures.

Критерии исключения

An individual who meets any of these criteria will be excluded from SONIC-GCA:

• Referral for a suspected GCA relapse.
• Current use of systemic glucocorticoids, with the following duration at the baseline visit: ≥ 14 consecutive days of oral glucocorticoids in the previous 30 days, or ≥ 7 consecutive days of oral glucocorticoids if intravenous glucocorticoids were administered in the previous 30 days.
• Current use of any conventional or biologic immunosuppressive therapy.
• Known previous medical history of retinal diseases, optic nerve diseases, demyelinating diseases, normotensive hydrocephalus, intracranial tumors (benign or malignant), or any conditions associated with intracranial hypertension.
• Any condition that impairs the ability to perform optic nerve sheath ultrasound or fundoscopy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Канада · 6 центров

• St-Joseph's Health Care London — London
• Sinai Health - Toronto — Toronto
• MUHC - McGill University — Montreal
• Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal — Montreal
• CIUSSS de l'Est-de-l'ile de Montreal — Montreal
• CIUSSS de l'Estrie - CHUS — Sherbrooke

Идентификаторы

NCT: NCT05749094 · 20201890

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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