GIMIAS® Tool Validation for the Detection of Left Atrium Fibrosis Through Late Enhancement Magnetic Resonance Image Processing. Pattern Determination in a Cohort of Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Proportion of subjects with contrast enhancement in left atrium, measured through the reconstruction and processing of late enhancement magnetic resonance images with GIMIAS.
研究概览
简要总结
The purpose of this study is to validate the technique for the detection of left atrial fibrosis through segmentation of endocardial and epicardium landmarks of the images obtained with 3 Tgadobutrol-enhanced magnetic resonance with the software GIMIAS® in a cohort of healthy volunteers, without atrial fibrillation or known cardiovascular risk factors.
详细描述
3D reconstructions obtained by GIMIAS® will be evaluated. Processing images will be carried out by two independent operators, and will calculate the kappa interobserver agreement .
Subsequently, the processed images are compared with images previously obtained in 10 patients with persistent atrial fibrillation adjusted for sex and age. A qualitative visual comparison will be made.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers capable of being subjected to the prespecified tests of the study.
- •Healthy volunteers that sign the informed consent after being informed.
排除标准
- •Healthy volunteers with:
- •A medical history of atrial fibrillation, hypertension or diabetes mellitus.
- •A medical history of heart disease, structural, ischemic or arrhythmic.
- •A medical history of chronic obstructive pulmonary disease/obstructive sleep apnoea/hypopnoea syndrome
- •Sport habits: intense sport activities during three or more hours in a week
- •Any assumption that contraindicates the magnetic resonance and/or the use of gadolinium or other contrast mediums, including a medical history of previous allergic or not allergic reactions with the use of gadolinium or other contrast mediums, bronchial asthma or allergic diseases.
- •Pregnancy or breast feeding.
研究组 & 干预措施
Gadobutrol
Gadobutrol in Healthy volunteers
干预措施: gadobutrol (Drug)
结局指标
主要结局
Proportion of subjects with contrast enhancement in left atrium, measured through the reconstruction and processing of late enhancement magnetic resonance images with GIMIAS.
时间窗: Baseline
次要结局
- Interobserver variability in the generation of segmented images of left atrium, measured through the kappa index.(1 week after intervention)
- Adverse events(1 week after intervention)
研究者
Sara Varea
Clinical Research Manager
Fundacion Clinic per a la Recerca Biomédica