Cardiac Magnetic Resonance in Patients With Giant Cell Arteritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Differences in myocardial mapping between GCA patients and a healthy control
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed GCA
排除标准
- •MRI contraindications (e.g. non-compartible pacemaker)
结局指标
主要结局
Differences in myocardial mapping between GCA patients and a healthy control
时间窗: 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.
次要结局
未报告次要终点
研究者
Alexander Isaak
Radiologist, , Radiology Clinic
University Hospital, Bonn
