Multimodal Assessment of Biomarkers for Diagnosing Giant Cell Arteritis and Polymyalgia Rheumatica: A Comprehensive Analysis of Clinical, Laboratory, and Imaging Profiles

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• Informed Consent: Participants (\>18 years) must provide written informed consent to voluntarily participate in the study.

• Confirmed Diagnosis: Diagnosis of GCA or PMR confirmed by the treating physician and fulfilling expanded ACR-EULAR classification criteria. Patients must have been either newly diagnosed within the last three days or have experienced a disease flare within the same timeframe.

Locations
Other Locations
Germany
University Hospital Bonn
RECRUITING
Bonn
Contact Information
Primary
Simon M. Petzinna, Dr. med.
Simon_Michael.Petzinna@ukbonn.de
0049 151 582 337 07
Backup
Valentin S. Schäfer, Univ. Prof.
valentin.Schaefer@ukbonn.de
0049 228 287 17016
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 100
Treatments
PMR/ GCA
Patients diagnosed with GCA and/or PMR will be enrolled in this cohort. They will undergo a series of interventions including immunological profiling (cytokine profiling and immune cell phenotyping using flow cytometry, ELISA, 3'mRNA sequencing, high content analysis via a cell-based ex-vivo assay), and diagnostic imaging (MRI, OCTA including further ophthalmological assessment, vascular and transorbital ultrasound. Samples will be collected from patients at various stages of the disease (t=0, t=6, t=12, t=18 months, during flare-ups). Furthermore, TAB will be stained with a VAP-1 antibody to assess the expression and localization of VAP-1 in the arterial tissue.
Control Group
Age- and gender-matched healthy subjects will serve as the control group to provide baseline data for comparative purposes. This group will not receive any treatment related to GCA or PMR but undergoes similar diagnostic procedures for baseline measurements, including imaging and immunological assessments.
Sponsors
Leads: University of Bonn

This content was sourced from clinicaltrials.gov