NCT Number: NCT06894602
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Chu Brest, Brest, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At 12 months
Relapse is defined with European League Against Rheumatism recommendations according to major or minor relapse criteria.
Time frame: At 6 month; at 12 month
Relapse is defined with European League Against Rheumatism recommendations according to major or minor relapse criteria.
Time frame: At inclusion
One Clinical parameter is defined with the dichotomised variable : age > 50 years (YES) and age <=50 years (NO)
Time frame: At inclusion, At 6 month, At 12 month
Pronostic markers are defined with C-Reactive Protein (in mg/L)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: At inclusion
One Clinical parameter is defined with the sudden loss of vision (YES/NO)
Time frame: At inclusion
One Clinical parameter is defined with the claudication of the jaw or tongue (YES/NO)
Time frame: At inclusion
One Clinical parameter is defined with the temporal headaches (YES/NO)
Time frame: At inclusion
One Clinical parameter is defined with the scalp paresthesia (YES/NO)
Time frame: At inclusion
One Clinical parameter is defined with the abnormal palpation of the temporal arteries (YES/NO)
Time frame: At inclusion
One Clinical parameter is defined with morning stiffness of shoulders and/or neck (YES/NO)
Time frame: At inclusion
One biological parameter is defined with positive temporal artery biopsy (YES/NO)
Time frame: At inclusion
One biological parameter is defined with halo sign on ultrasound (Present/Absent)
Time frame: 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)
Time frame: At inclusion
One biological parameter is defined with aortitis on PET scans of the thoracic or abdominal descending aorta (Present/Absent)
Time frame: At inclusion
One biological parameter is defined with Sedimentation rate >= 50 mm/hour (YES/NO)
Time frame: At inclusion
One biological parameter is defined with C-Reactive Protein >= 10 mg/L at the first hour (YES/NO)
Time frame: At inclusion, At 6 month, At 12 month
Pronostic markers are defined with hemoglobin (in g/dL)
Time frame: At inclusion, At 6 month, At 12 month
Pronostic markers are defined with leukocytes (in giga/L)
Time frame: At inclusion, At 6 month, At 12 month
Pronostic markers are defined with platelets (in giga/L)
Time frame: At inclusion, At 6 month, At 12 month
Pronostic markers are defined with Sedimentation rate (in mm/hour)
Contact information is provided by the study sponsor or research team.
University Hospital, Brest
Other
Acronym: ALERT
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