Cardiac Involvement in Patients With Giant Cell Arteritis

NCT ID: NCT07031284

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-21
• Study Completion Date: 2025-05-14

Brief Summary

This prospective observational study aims to investigate whether patients with newly diagnosed giant cell arteritis (GCA) show signs of cardiac involvement. Using multiparametric cardiac magnetic resonance imaging (CMR), functional, structural, and tissue-specific cardiac parameters are assesed. All participants undergo CMR at baseline and a follow up CMR after approximately six months. Healthy controls are included for comparison. Results may help improve early detection and monitoring of cardiovascular complications in GCA.

Detailed Description

Giant cell arteritis (GCA) is a systemic inflammatory vasculitis of older adults, potentially involving the cardiovascular system. While aortic and vascular complications are well described, myocardial involvement remains understudied and often subclinical. GCA is associated with increased all-cause mortality and cardiovascular disease, therefore early detection of cardiovascular involvement is essential.

This prospective single-center study investigates myocardial tissue alterations in patients with newly diagnosed GCA using comprehensive multiparametric cardiac magnetic resonance imaging (CMR). All participants gave written informed consent prior to cardiac MRI. Diagnosis of GCA was established according to current clinical and ultrasound criteria. Only subjects without general contraindications for contrast-enhanced CMR were included (e.g., MRI-incompatible implants, known allergy to MRI contrast agents, severe renal impairment, brestfeeding, pregnancy, and claustrophobia). The CMR protocol includes native T1- and post contrast T1-, T2 mapping, late gadolinium enhancement (LGE), T2-weighted short-tau inversion-recovery sequences and functional cine imaging.

The study comprises a baseline CMR and a follow-up scan after approximately 6 months. The extracellular volume fraction (ECV) is calculated from pre and post-contrast T1-mapping and current hematocrit. Left and right ventricular function and volumes were assessed on short-axis cine images. Functional parameters were indexed to body surface area. Imaging results are correlated with inflammatory markers and clinical features. A healthy control group from historiacal datasets is used for comparison. Group comparisons are performed using t-tests, Mann-Whitney U, and chi-square tests; paired t-tests assessed longitudinal changes.

The study aims to evaluate the prevalence, pattern, and evolution of cardiac changes in GCA and explore their clinical relevance for cardiovascular risk stratification.

Conditions

Giant Cell Arteritis (GCA)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients with diagnosed GCA

Clinically diagnosed GCA-patients from the Department of Rheumatology.

No interventions assigned to this group

Healthy controls

Healthy control group from historical data

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• diagnosed GCA

Exclusion Criteria

• MRI contraindications (e.g. non-compartible pacemaker)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bonn

OTHER

Sponsor Role: lead

Responsible Party

Alexander Isaak

Radiologist, , Radiology Clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simon Petzinna, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bonn, Department of Rheumatology

Alexander Isaak, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bonn, Department of Radiology

Julian Luetkens, Prof. Dr.

Role: STUDY_DIRECTOR

University Hospital Bonn, Department of Radiology

Locations

University Hospital Bonn

Bonn, , Germany

Countries

Germany

Other Identifiers

2020-475-BON

Identifier Type: -

Identifier Source: org_study_id