Giant Cell Arteritis (GCA)NCT07031284
Cardiac Involvement in Patients With Giant Cell Arteritis
An observational study of Giant Cell Arteritis (GCA), run by University Hospital, Bonn at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Giant Cell Arteritis (GCA)
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 21 Dec 2022to 14 May 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 45 GCA-diagnosed patients (mean age 73 years, SD 9; 42% female)
Who may be able to join
- diagnosed GCA
Who cannot join
- MRI contraindications (e.g. non-compartible pacemaker)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac Magnetic Resonance 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.
Read the 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)
- Keywords
- Cardiac Magnetic Resonance Imaging, Giant Cell Arteritis, Cardiovascular Disease, Tissue Characterization, Myocardial Disease
- Medical subject headings
- Giant Cell Arteritis, Cardiovascular Diseases, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with diagnosed GCA | Clinically diagnosed GCA-patients from the Department of Rheumatology. | |
| Healthy controls | Healthy control group from historical data |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline Cardiac MRI was performed in an avarage of 31 days after first symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start21 Dec 2022
- Primary completion14 May 2025
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell Arteritis (GCA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Isaak, University Hospital, Bonn
- Investigators
- Simon Petzinna, Dr., Principal investigator, University Hospital Bonn, Department of RheumatologyAlexander Isaak, PD Dr., Principal investigator, University Hospital Bonn, Department of RadiologyJulian Luetkens, Prof. Dr., Study director, University Hospital Bonn, Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031284
- Sponsor's protocol ID
- 2020-475-BON
- Status last verified
- Jul 2025
- First submitted
- 12 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Magnetic Resonance in Patients With Giant Cell Arteritis
- ClinicalTrials.gov ID
- NCT07031284
- Acronym / sponsor ID
- 2020-475-BON
- Conditions
- Giant Cell Arteritis (GCA)
- Keywords
- Cardiac Magnetic Resonance Imaging, Giant Cell Arteritis, Cardiovascular Disease, Tissue Characterization, Myocardial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with diagnosed GCA | – | –Clinically diagnosed GCA-patients from the Department of Rheumatology. |
| Healthy controls | – | –Healthy control group from historical data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 45 GCA-diagnosed patients (mean age 73 years, SD 9; 42% female)
Key inclusion criteria (1 listed)
- diagnosed GCA
Key exclusion criteria (1 listed)
- MRI contraindications (e.g. non-compartible pacemaker)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Petzinna, Dr. principal investigator
University Hospital Bonn, Department of Rheumatology
Alexander Isaak, PD Dr. principal investigator
University Hospital Bonn, Department of Radiology
Julian Luetkens, Prof. Dr. study director
University Hospital Bonn, Department of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Arteritis (GCA), run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.