NCT03119090已完成不适用
Cross-sectional Analysis of Non-invasive Measures of Ventricular Systolic and Diastolic Function and Biomarkers in the Fontan Circulation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Biomarkers
研究概览
简要总结
The goal of the Fontan Imaging Biomarkers (FIB) study is to identify the associations of blood and urine biomarkers to imaging parameters of ventricular mechanics.
详细描述
This study has the following research questions:
- What is the reproducibility of ventricular systolic function measurements (including ventricular strain) in Fontan patients using echocardiography (Echo) and cardiac magnetic resonance imaging (CMR)?
- What is the reproducibility of ventricular diastolic function measurements (including tissue Doppler and strain rate) in Fontan patients using Echo and CMR?
- Is there a correlation between ventricular function measurements and circulating biomarkers (including galectin-3 levels, NT-proBNP, ST2, and MELD-XI score)?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with Fontan circulation undergoing clinically indicated CMR at Boston Children's Hospital will be considered for the study
排除标准
- •Inadequate imaging quality to perform proposed analysis
- •Patients <15 kg will be excluded to simplify compliance with BCH minimal risk research blood draw volume guidelines (minimal risk is defined as < 5% total blood volume)
结局指标
主要结局
Biomarkers
时间窗: Through study completion, an average of 3 years
Correlation of biomarkers and imaging parameters of ventricular mechanics
次要结局
- Systolic function(Through study completion, an average of 3 years)
- Diastolic function(Through study completion, an average of 3 years)
研究者
Rahul Rathod
Cardiologist
Boston Children's Hospital
研究点 (1)
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