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OpenTrials
Completed

NCT Number: NCT07031284

Cardiac Involvement in Patients With Giant Cell Arteritis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed GCA

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Differences in myocardial mapping between GCA patients and a healthy control

    Time frame: Baseline Cardiac MRI was performed in an avarage of 31 days after first symptoms

    Quantitative assessment of native myocardial T1, T2, and extracellular volume (ECV) by cardiac MRI at baseline to evaluate subclinical myocardial involvement in patients with newly diagnosed giant cell arteritis compared to healthy controls.

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Official study title

Cardiac Magnetic Resonance in Patients With Giant Cell Arteritis

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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