Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic

Trial design

Treatments tested in this trial

• Aortic/ cardiac magnetic resonance imaging

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  MRI scans will be performed to detect systemic vascular involvement in GCA patients, aiming to provide detailed images of affected tissues.

• Vascular ultrasound

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  Vascular ultrasound will be employed to examine the temporal and axillary arteries in GCA patients, searching for signs indicative of active inflammation.

• Transorbital Ultrasound

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  Transorbital ultrasound will be employed to assess the ophthalmic artery and its branches in GCA patients to detect intracranial inflammatory processes that could lead to severe neuro-ophthalmological complications.

• Contrast-Enhanced Ultrasound

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  Contrast-Enhanced Ultrasound (CEUS) is utilized to evaluate aortic involvement in GCA patients as an alternative, bed-side, realtime, radiation-free diagnostic tool.

• Optical coherence tomography angiography

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  OCTA will be used to assess vascular changes in the retina of GCA patients, providing detailed imaging that can help detect early signs of ocular involvement and identify risk factors of anterior ischemic optic neuropathy.

• Fluorescein angiography

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  Fluorescein angiography will be performed to evaluate blood circulation and highlight any blockages in the blood vessels of the retina in patients with GCA to detect vascular abnormalities that may lead to severe vision complications.

• Fundus autofluorescence

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  This imaging technique will be used to observe the health of the retina and detect any changes in GCA patients that could suggest disease activity, particularly useful for assessing the integrity of the retinal pigment epithelium.

• Color Fundus Photography

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  Color fundus photography will be used to document the appearance of the optic disc and retinal vasculature in GCA patients, aiding in the long-term monitoring of ocular changes and the effects of therapeutic interventions.

• Cell-based ex-vivo assay with high-content analysis

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  This assay predicts individual patient responses to different DMARDs by analyzing patient-derived PBMCs for specific immune responses to therapeutic agents.

• 3'mRNA sequencing

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  3'mRNA sequencing analyzes gene expression profiles related to the immune response in PMR/GCA patients, aiding in understanding the genetic underpinnings of inflammation and vascular remodeling.

• Enzyme-linked immunosorbent assay

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  Used to measure cytokine levels in the serum and plasma of PMR/GCA patients, ELISA aids in profiling inflammatory markers that are indicative of disease activity and response to treatment.

• Flow cytometry

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  Employed to analyze immune cell phenotypes in patients with PMR and/or GCA, this test helps identify various immune cell subsets and their activation states, which are critical for understanding disease mechanisms and guiding therapy.

• Laboratory assessment:

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  Serum Chemistry (nt-proBNP, troponin T, CRP, ESR, blood count)

• Immunohistochemistry of Temporal Artery Biopsies

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  Immunohistochemistry staining of TAB to assess local expression of endothelial adhesion molecules in acute inflammation.

• Functional assessment questionnaires

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  The following questionnaires will be applied: FACIT-Fatigue, SF-36, BAS, Birmingham Vasculitis Activity Score, Montreal Cognitive Assessment, Mini-Mental Status Examination. These questionnaires collectively provide a comprehensive evaluation of the functional status, quality of life, and mental health of patients with GCA and PMR.

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