Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic
NCT Number: NCT06460142
Acronym: GCAIO
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Giant Cell Arteritis|Polymyalgia Rheumatica
Interventions: DIAGNOSTIC_TEST: Aortic/ cardiac magnetic resonance imaging|DIAGNOSTIC_TEST: Vascular ultrasound|DIAGNOSTIC_TEST: Transorbital Ultrasound|DIAGNOSTIC_TEST: Contrast-Enhanced Ultrasound|DIAGNOSTIC_TEST: Optical coherence tomography angiography|DIAGNOSTIC_TEST: Fluorescein angiography|DIAGNOSTIC_TEST: Fundus autofluorescence|DIAGNOSTIC_TEST: Color Fundus Photography|DIAGNOSTIC_TEST: Cell-based ex-vivo assay with high-content analysis|DIAGNOSTIC_TEST: 3'mRNA sequencing|DIAGNOSTIC_TEST: Enzyme-linked immunosorbent assay|DIAGNOSTIC_TEST: Flow cytometry|DIAGNOSTIC_TEST: Laboratory assessment:|DIAGNOSTIC_TEST: Immunohistochemistry of Temporal Artery Biopsies|DIAGNOSTIC_TEST: Functional assessment questionnaires
Sponsor: University of Bonn
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-09-01
Completion Date: 2027-09-30
Locations: University Hospital Bonn, Bonn, NRW, 53127, Germany

Summary:
The GCAIO study is an innovative, multimodal research initiative designed to enhance the understanding, diagnosis, and management of giant cell arteritis (GCA) and frequently associated polymyalgia rheumatica (PMR). This longitudinal study aims to dissect the complex immunological landscape and systemic manifestations of these conditions through a combination of diagnostic imaging and detailed immunological profiling.

The study focuses on three primary objectives: (1) Identifying and analyzing cytokine profiles and immune cell phenotypes, employing techniques like flow cytometry, enzyme-linked immunosorbent assays (ELISA), and next-generation sequencing to predict disease activity and therapeutic responses. (2) Advancing diagnostic and monitoring capabilities through the application of novel and established imaging technologies, including MRI, optical coherence tomography angiography (OCTA), and ultrasound. These modalities aim to improve the detection of neuro-ophthalmological, cardiac, and aortic complications in GCA, potentially offering more precise monitoring and earlier diagnosis. (3) Enhancing the understanding of PMR within the context of GCA by exploring specific biomarkers and advanced imaging to refine diagnostic accuracy and treatment strategies, thus improving patient outcomes.

Primary Outcome Measures: Number of Participants with Detected Neuro-Ophthalmological Manifestations, Use of OCTA, TOS, and additional ocular imaging to assess and monitor ocular and cranial vascular abnormalities indicative of GCA. Unit of Measure: Number of participants., At baseline, 3 months, 6 months, 9 months, 12 months, 18 months, and during flare-ups (assessed up to 18 months after diagnosis).|Number of Participants with Detected Cardiac and Aortic Involvement, Detection and monitoring of inflammatory changes and structural anomalies in the cardiac and aortic regions using MRI and CEUS. Unit of Measure: Number of participants., At baseline, 6 months, 12 months, 18 months, and during flare-ups (assessed up to 18 months after diagnosis).|Changes in Immune Cell Phenotype, Identification and quantification of immune cell types including changes over time using FACS. Unit of Measure: Changes in levels (percentages)., At baseline, 6 months, 12 months, 18 months, and during flare-ups (assessed up to 18 months after diagnosis).|Changes in Cytokine Profiles, Identification and quantification of cytokines including changes over time using 3'-mRNA transcriptome analysis. Unit of Measure: Changes in levels (pg/mL)., At baseline, 6 months, 12 months, 18 months, and during flare-ups (assessed up to 18 months after diagnosis).|Levels of Siglec-9 in Blood, Measurement of Siglec-9 levels on immune cells including changes over time using FACS. Correlation with clinical assessments of disease activity and imaging findings. Unit of Measure: Changes in levels (percentages)., At baseline, 6 months, 12 months, 18 months, and during flare-ups (assessed up to 18 months after diagnosis).|Levels of sVAP-1 in Blood, Measurement of sVAP-1 levels in blood via ELISA including changes over time. Correlation with clinical assessments of disease activity and imaging findings. Unit of Measure: Changes in levels (ng/mL)., At baseline, 6 months, 12 months, 18 months, and during flare-ups (assessed up to 18 months after diagnosis).