[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551442":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":110,"centralContacts":115,"locations":124,"responsibleParty":142,"collaborators":10,"id":146,"slug":10,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":153,"sex":154,"minAge":155,"maxAge":10,"enrollmentInfo":156,"targetDuration":10,"studyType":159,"phases":10,"briefSummary":160,"conditions":161,"keywords":164,"overallStatus":127,"whyStopped":10,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},{"fullName":5,"class":6},"University of Bonn","OTHER",[8,28],{"label":9,"type":10,"description":11,"interventionNames":12},"PMR\u002F GCA",null,"Patients diagnosed with GCA and\u002For 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.",[13,14,15,16,17,18,19,20,21,22,23,24,25,26,27],"Diagnostic Test: Aortic\u002F 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",{"label":29,"type":10,"description":30,"interventionNames":31},"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.",[13,14,15,16,17,18,19,20,21,22,23,24,25,27],[33,40,44,50,56,62,66,70,74,80,84,90,96,100,106],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DIAGNOSTIC_TEST","Aortic\u002F cardiac magnetic resonance imaging","MRI scans will be performed to detect systemic vascular involvement in GCA patients, aiming to provide detailed images of affected tissues.",[29,9],[39],"Aortic\u002F cardiac MRI",{"type":34,"name":41,"description":42,"armGroupLabels":43,"otherNames":10},"Vascular ultrasound","Vascular ultrasound will be employed to examine the temporal and axillary arteries in GCA patients, searching for signs indicative of active inflammation.",[29,9],{"type":34,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Transorbital Ultrasound","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.",[29,9],[49],"TOS",{"type":34,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Contrast-Enhanced Ultrasound","Contrast-Enhanced Ultrasound (CEUS) is utilized to evaluate aortic involvement in GCA patients as an alternative, bed-side, realtime, radiation-free diagnostic tool.",[29,9],[55],"CEUS",{"type":34,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"Optical coherence tomography angiography","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.",[29,9],[61],"OCTA",{"type":34,"name":63,"description":64,"armGroupLabels":65,"otherNames":10},"Fluorescein angiography","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.",[29,9],{"type":34,"name":67,"description":68,"armGroupLabels":69,"otherNames":10},"Fundus autofluorescence","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.",[29,9],{"type":34,"name":71,"description":72,"armGroupLabels":73,"otherNames":10},"Color Fundus Photography","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.",[29,9],{"type":34,"name":75,"description":76,"armGroupLabels":77,"otherNames":78},"Cell-based ex-vivo assay with high-content analysis","This assay predicts individual patient responses to different DMARDs by analyzing patient-derived PBMCs for specific immune responses to therapeutic agents.",[29,9],[79],"GCAIO-essay",{"type":34,"name":81,"description":82,"armGroupLabels":83,"otherNames":10},"3'mRNA sequencing","3'mRNA sequencing analyzes gene expression profiles related to the immune response in PMR\u002FGCA patients, aiding in understanding the genetic underpinnings of inflammation and vascular remodeling.",[29,9],{"type":34,"name":85,"description":86,"armGroupLabels":87,"otherNames":88},"Enzyme-linked immunosorbent assay","Used to measure cytokine levels in the serum and plasma of PMR\u002FGCA patients, ELISA aids in profiling inflammatory markers that are indicative of disease activity and response to treatment.",[29,9],[89],"ELISA",{"type":34,"name":91,"description":92,"armGroupLabels":93,"otherNames":94},"Flow cytometry","Employed to analyze immune cell phenotypes in patients with PMR and\u002For GCA, this test helps identify various immune cell subsets and their activation states, which are critical for understanding disease mechanisms and guiding therapy.",[29,9],[95],"FACS",{"type":34,"name":97,"description":98,"armGroupLabels":99,"otherNames":10},"Laboratory assessment:","Serum Chemistry (nt-proBNP, troponin T, CRP, ESR, blood count)",[29,9],{"type":34,"name":101,"description":102,"armGroupLabels":103,"otherNames":104},"Immunohistochemistry of Temporal Artery Biopsies","Immunohistochemistry staining of TAB to assess local expression of endothelial adhesion molecules in acute inflammation.",[9],[105],"IHC TAB",{"type":34,"name":107,"description":108,"armGroupLabels":109,"otherNames":10},"Functional assessment questionnaires","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.",[29,9],[111],{"name":112,"affiliation":113,"role":114},"Valentin S. Schäfer, Univ. Prof.","Department of Rheumatology and Clinical Immunology, University Hospital Bonn","PRINCIPAL_INVESTIGATOR",[116,121],{"name":117,"role":118,"phone":119,"phoneExt":10,"email":120},"Simon M. Petzinna, Dr. med.","CONTACT","0049 151 582 337 07","Simon_Michael.Petzinna@ukbonn.de",{"name":112,"role":118,"phone":122,"phoneExt":10,"email":123},"0049 228 287 17016","valentin.Schaefer@ukbonn.de",[125],{"facility":126,"status":127,"city":128,"state":129,"zip":130,"country":131,"cosmosGeoPoint":132,"geoPoint":137,"contacts":138},"University Hospital Bonn","RECRUITING","Bonn","North Rhine-Westphalia","53127","Germany",{"type":133,"coordinates":134},"Point",[135,136],7.09549,50.73438,{"lat":136,"lon":135},[139,140],{"name":117,"role":118,"phone":119,"phoneExt":10,"email":120},{"name":112,"role":118,"phone":122,"phoneExt":10,"email":141},"Valentin.Schaefer@ukbonn.de",{"type":114,"investigatorFullName":143,"investigatorTitle":144,"investigatorAffiliation":145,"oldNameTitle":10,"oldOrganization":10},"Valentin Schäfer","Univ. Prof. Dr. med. Valentin Sebastian Schäfer","University Hospital, Bonn","100551442",false,"NCT06460142","Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic","Multimodal Assessment of Biomarkers for Diagnosing Giant Cell Arteritis and Polymyalgia Rheumatica: A Comprehensive Analysis of Clinical, Laboratory, and Imaging Profiles","GCAIO","Inclusion Criteria:\n\n* Informed Consent: Participants (\\>18 years) must provide written informed consent to voluntarily participate in the study.\n* 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.\n\nExclusion Criteria:\n\n* Severe Renal Insufficiency: Chronic glomerular filtration rate (GFR) less than 30 mL\u002Fmin.\n* Other Medical Conditions Requiring Glucocorticoids: Presence of medical conditions other than GCA or PMR that necessitate continuous or intermittent treatment with oral or parenteral glucocorticoids.\n* Other Inflammatory Rheumatic Diseases: Patients with other inflammatory rheumatic diseases.",true,"ALL","18 Years",{"count":157,"type":158},100,"ESTIMATED","OBSERVATIONAL","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.\n\nThe 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.",[162,163],"Giant Cell Arteritis","Polymyalgia Rheumatica",[162,163,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179],"Vasculitis","Inflammatory Disorders","Clinical Biomarkers","Predictive Biomarkers","Disease Activity Monitoring","Therapeutic Response","Diagnostic Imaging Techniques","Aortic Imaging","Magnetic Resonance Imaging (MRI)","Vascular Ultrasound","Optical Coherence Tomography Angiography (OCT-A)","Transcriptome Analysis","Vascular-adhesion protein 1","Positron emission tomography-computed tomography (PET\u002FCT)","Siglec-9","2025-04-07",{"date":182,"type":183},"2025-04-10","ACTUAL",{"date":185,"type":183},"2023-09-01",{"date":187,"type":158},"2027-09-30",{"name":5,"class":6},1]