Optimization of Thoracic Aortic MRI Acquisition Sequences for the Quantification of Diagnostic-assisting Biomarkers (SEQUOIA)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Parametric measurement of thoracic aorta values of normal subjects
研究概览
简要总结
The main objective is to optimize MRI acquisition and image post-processing protocols in order to define the best compromise between short scan time and image quality (contrast between different tissues, spatial and temporal resolutions) high enough to accurately measure morphologic, hemodynamic and structural aortic biomarkers.
详细描述
This Magnetic Resonance imaging study of the thoracic aorta aims to: 1- enhance patient comfort during the examination, shorten appointment waiting times and overall reduce MRI cost, and 2- provide a reliable diagnosis and risk assessment of aorta-related diseases occurring in hypertension, obesity or diabetes but also throughout normal aging.
The impact of MRI acquisition innovations on the measurement of biomarkers that are extracted from image post-processing software and therein on disease characterization (normal values, severity thresholds, etc.) must be systematically reevaluated. More specifically, the investigators design image acquisition and automated image processing methods to reduce operator variability. This study will optimize thoracic aortic MRI acquisition sequences for the quantification of diagnostic-assisting biomarkers in a healthy population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject aged between 20 and 35 or between 50 and 70 (limits included)
- •BMI < 30 kg/m²
- •Asymptomatic subject
- •Having given informed, free and written consent
- •Affiliated to a French social security scheme or entitled
排除标准
- •Contraindication to MRI (claustrophobia, presence of a metallic foreign body)
- •Pregnant or breastfeeding woman
- •Known cardiac pathology
- •Personal cardiovascular history
- •Person deprived of liberty by court decision or benefiting from legal protection (under guardianship or curatorship)
- •Abuse of alcohol or narcotics
- •Subject under AME
- •Participation in another interventional research involving the human person or being in the exclusion period at the end of a previous research involving the human person
结局指标
主要结局
Parametric measurement of thoracic aorta values of normal subjects
时间窗: 24 months
Thoracic aorta values measured by MRI
次要结局
- Quantitative periaortic fat (g and g/m², when indexed to BSA)(24 months)
- ROC metrics will be used to compare the various sequences (%)(24 months)
- Intra and inter-reproductibility of aortic measures will be assessed (intra-class correlation coefficients)(24 months)
- Quantitative fibrosis within the aortic wall (%)(24 months)
- Quantitative flow values within the different aortic segments and the main branches (mL)(24 months)
- Correlation coefficients will be estimated to assess the associations between novel and conventional biomarkers(24 months)
- Intra and inter-reproductibility of aortic measures will be assessed (Bland and Altman metrics)(24 months)
- Quantitative fat within the aortic wall (%)(24 months)