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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00141-48 | Other Identifier | ANSM |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orbital ultrasounds | Experimental | Orbital ultrasounds on patients suspected of GCA at the enrollment (M0) and at 6 months if the suspicion of GCA is confirmed after all the tests realized at the enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| orbital ultrasound | Diagnostic Test | orbital ultrasound at the beginning of the participation, and at 6 months after the inclusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Assess whether the Optic Nerve Sheath Diameter (ONSD) measured by orbital ultrasound serves as an effective diagnostic marker for Giant Cell Arteritis (GCA) | Area under the ROC curve (AUC) of the optic nerve sheath measurements obtained by ultrasound during the enrollment phase, using the final clinical expert diagnosis at 6 months as the reference standard. The clinical expert's evaluation will be blinded to the optic nerve sheath measurements. | At the patient enrollment visit and at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the reproducibility of the optic nerve sheath diameter (ONSD) measurements by ultrasound. | Mean bias according to Bland-Altman analysis, limits of agreement with their confidence intervals, maximum acceptable difference (clinical and statistical difference calculated using the root sum of squares of the coefficients of variation), inter-rater ICC. | At the patient enrollment visit and at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maryline DELATTRE | Contact | +330130754131 | maryline.delattre@ght-novo.fr | |
| Mathilde WLODARCZYK | Contact | +330130754040 | 7199 | mathilde.wlodarczyk@ght-novo.fr |
| Name | Affiliation | Role |
|---|---|---|
| Omar AL TABAA, Dr | Hôpital NOVO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhumatology departement - Centre Hospitalier Aix en Provence | Not yet recruiting | Aix-en-Provence | France |
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| ID | Term |
|---|---|
| D013700 | Giant Cell Arteritis |
| ID | Term |
|---|---|
| D020293 | Vasculitis, Central Nervous System |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
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| Evaluate the diagnostic performance of ONSD in GCA. | Sensitivity, specificity, ROC curve inflection point (pathological threshold value), positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio. | At the patient enrollment visit and at 6 months |
| Study the evolution of ONSD under treatment between M0 and M6 in patients with GCA. | Measurement of the optic nerve sheath diameter (ONSD) by ultrasound at baseline (within 3 days of corticosteroid initiation) in all patients, and at 6 months in patients with GCA. | At the patient enrollment visit and at 6 months |
| Exploratory evaluation of ONSD according to the presence or absence of extracranial GCA. | Comparison of mean ONSD between subgroups: cranial GCA, extracranial GCA, and GCA-negative patients. | At the patient enrollment visit and at 6 months |
| Exploratory evaluation of ONSD based on the presence or absence of GCA with visual involvement. | Comparison of mean ONSD between subgroups: GCA with visual involvement, GCA without visual involvement, and GCA-negative patients | At the patient enrollment visit and at 6 months |
| Assess the feasibility of ultrasound as a diagnostic tool for GCA. | Description of the patient flow : average duration of the exam | At the patient enrollment visit and at 6 months |
| Assess the feasibility of ultrasound as a diagnostic tool for GCA. | Description of the patient flow : percentage of exams performed, and percentage of interpretable exams. | At the patient enrollment visit and at 6 months |
| Assess the feasibility of ultrasound as a diagnostic tool for GCA. | Description of the patient flow : number of exams performed, and number of interpretable exams. | At the patient enrollment visit and at 6 months |
| Rhumatology department - Centre Hospitalier Universitaire de Brest | Not yet recruiting | Brest | France |
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| Internal Medecine Department- CHU Caen | Recruiting | Caen | France |
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| Internal Medicine and Clinical Immulogy department - Centre Hospitalier Universitaire de Dijon | Not yet recruiting | Dijon | France |
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| Internal Medicine and VascularMedecine Department - Centre Hospitalier Universitaire de Nantes | Not yet recruiting | Nantes | France |
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| Internal Medicine department - Hôpital Saint-Antoine | Not yet recruiting | Paris | France |
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| Rhumatology department - Hôpital Bichat | Not yet recruiting | Paris | France |
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| Rhumatology department - Hôpital NOVO - Pontoise site | Not yet recruiting | Pontoise | France |
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| Rhumatology department - Centre Hospitalier Universitaire de Tours | Not yet recruiting | Tours | France |
|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001167 | Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |