Cardiac Involvement in Patients With Giant Cell Arteritis

NCT07031284 | Completed

• 1 other identifier: 2020-475-BON
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Giant Cell Arteritis (GCA)

Keywords

Cardiac Magnetic Resonance Imaging; Giant Cell Arteritis; Cardiovascular Disease; Tissue Characterization; Myocardial Disease

Outcome Measures

Primary Outcomes (1)

• Differences in myocardial mapping between GCA patients and a healthy control

  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.

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

Study Arms (2)

Patients with diagnosed GCA

Clinically diagnosed GCA-patients from the Department of Rheumatology.

Healthy controls

Healthy control group from historical data

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

45 GCA-diagnosed patients (mean age 73 years, SD 9; 42% female)

You may qualify if:

• diagnosed GCA

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

University Hospital Bonn

Bonn, 53127, Germany

Location

MeSH Terms

Conditions

Giant Cell Arteritis; Cardiovascular Diseases; Cardiomyopathies

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Heart Diseases

Study Officials

• Simon Petzinna, Dr.

  University Hospital Bonn, Department of Rheumatology

  PRINCIPAL INVESTIGATOR

• Alexander Isaak, PD Dr.

  University Hospital Bonn, Department of Radiology

  PRINCIPAL INVESTIGATOR

• Julian Luetkens, Prof. Dr.

  University Hospital Bonn, Department of Radiology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiologist, , Radiology Clinic

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: December 21, 2022
• Primary Completion: May 14, 2025
• Study Completion: May 14, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

DE (1)