Giant Cell Arteritis
Conditions
Keywords
giant cell arteritis, Ultrasound, follow up, monitoring, OGUS score
Brief summary
Ultrasound evaluation of the temporal and axillary arteries is currently well recognized in the field of giant cell arteritis (GCA), a disease primarily affecting medium- and large-caliber vessels. Structural ultrasound abnormalities are now well described in this pathology, but their association with relapse and clinical concordance is unknown. There is currently a follow-up score (the OGUS score) for medium- and large-caliber arteries that could also predict the clinical course of the disease.
Detailed description
Prospective bicentric longitudinal study evaluating the association between ultrasound lesions and clinico-biological relapse in patients with giant cell arteritis. This is a non-interventional study with patients routinely followed for their pathology and classically benefiting from temporal artery ultrasound as part of their disease. Recruitment will be facilitated by the fact that these will be "general population" patients with suspected giant cell arteritis. The center will enroll 100 patients. The study will take place over 3 visits, including a clinical, biological and ultrasound examination. Ultrasound will not be blinded to the clinic, so we will only need one examiner in the center. This is a study in routine care, with no additional costs and no expected constraints. The ultrasound examination will be performed as part of their routine follow-up.
Interventions
None listed
Sponsors
University Hospital, Brest
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Major patient * Patients meeting ACR 2022 criteria for giant cell arteritis. * No opposition expressed
Exclusion criteria
* Patients unable to understand the protocol, under guardianship or curatorship. * Patients not affiliated to the French Social Security system.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse according to EULAR 2018 criteria | At 12 months | Relapse is defined with European League Against Rheumatism recommendations according to major or minor relapse criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relapse according to EULAR 2018 criteria | At 6 month; at 12 month | Relapse is defined with European League Against Rheumatism recommendations according to major or minor relapse criteria. |
| Clinical parameter : Age | At inclusion | One Clinical parameter is defined with the dichotomised variable : age \> 50 years (YES) and age \<=50 years (NO) |
| Other prognostic marker : C-Reactive Protein | At inclusion, At 6 month, At 12 month | Pronostic markers are defined with C-Reactive Protein (in mg/L) |
| OMERACT Giant Cells arteritis Ultrasonography Score (OGUS) | At 6 month, at 12 month | It is a score for ultrasound monitoring of temporal arteries by measuring the intima media complex of 8 vascular sites (common temporal trunk, frontal and parietal branches, axillary arteries). If OGUS score is \>= 1, the criteria is YES, if OGUS score \< 1, the criteria is NO |
| C-Reactive Protein | At 6 month, at 12 month | It is a biological marker expressed in mg/L. If CRP \>=10 mg/L, the criteria is YES. If CRF \< 10 mg/L, the criteria is NO |
| Erythrocyte Sedimentation Rate (ESR) | At 6 month, at 12 month | It is a blood test that can show the inflammation in the body, in mm/hour. If ESR \>= 15 mm/h, the criteria is YES. If ESR \< 15 mm/h, the criteria is NO. |
| Clinical parameter : loss of vision | At inclusion | One Clinical parameter is defined with the sudden loss of vision (YES/NO) |
| Clinical parameter : claudication of the jaw or tongue | At inclusion | One Clinical parameter is defined with the claudication of the jaw or tongue (YES/NO) |
| Clinical parameter : temporal headaches | At inclusion | One Clinical parameter is defined with the temporal headaches (YES/NO) |
| Clinical parameter : scalp paresthesia | At inclusion | One Clinical parameter is defined with the scalp paresthesia (YES/NO) |
| Clinical parameter : abnormal palpation of the temporal arteries | At inclusion | One Clinical parameter is defined with the abnormal palpation of the temporal arteries (YES/NO) |
| Clinical parameter : morning stiffness of shoulders and/or neck | At inclusion | One Clinical parameter is defined with morning stiffness of shoulders and/or neck (YES/NO) |
| Biological parameter : temporal artery biopsy | At inclusion | One biological parameter is defined with positive temporal artery biopsy (YES/NO) |
| Biological parameter : halo sign on ultrasound | At inclusion | One biological parameter is defined with halo sign on ultrasound (Present/Absent) |
| Biological parameter : bilateral axillary involvement | At inclusion | One biological parameter is defined with bilateral axillary involvement (occlusion or stenosis visualized on ultrasound or CT angio or PET scan or MRI)(Present/Absent) |
| Biological parameter : aortitis | At inclusion | One biological parameter is defined with aortitis on PET scans of the thoracic or abdominal descending aorta (Present/Absent) |
| Biological parameter : Sedimentation rate | At inclusion | One biological parameter is defined with Sedimentation rate \>= 50 mm/hour (YES/NO) |
| Biological parameter : C-Reactive Protein | At inclusion | One biological parameter is defined with C-Reactive Protein \>= 10 mg/L at the first hour (YES/NO) |
| Other prognostic marker : hemoglobin | At inclusion, At 6 month, At 12 month | Pronostic markers are defined with hemoglobin (in g/dL) |
| Other prognostic marker : leukocytes | At inclusion, At 6 month, At 12 month | Pronostic markers are defined with leukocytes (in giga/L) |
| Other prognostic markers : platelets | At inclusion, At 6 month, At 12 month | Pronostic markers are defined with platelets (in giga/L) |
| Other prognostic marker : Sedimentation rate | At inclusion, At 6 month, At 12 month | Pronostic markers are defined with Sedimentation rate (in mm/hour) |
Countries
France
Contacts
CONTACTSandrine Pr JOUSSE-JOULIN
Outcome results
None listed