Clinical Value of 18F-sodium Fluoride Uptake at the Aortic Valve for Prediction of the Progression in Patients With Moderate Aortic Stenosis: a Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 28
- 主要终点
- mean PG
研究概览
简要总结
This study aims to evaluate whether baseline 18F-sodium fluoride uptake activity at aortic valve could predict aortic stenosis progression in moderate aortic stenosis.
Patients with moderate aortic stenosis are enrolled and underwent baseline evaluation including 18F-sodium fluoride PET/CT. After 1 year, all the participants underwent follow-up echocardiography. The study design is an observational trial. Primary endpoint was a change in mean pressure gradient along the aortic valve as assessed by echocardiography at 1 year. Secondary endpoints include changes in aortic valve area, and symptom occurrence.
详细描述
Recent studies demonstrated 18F-sodium fluoride (NaF) uptake activity as a marker of early-stage calcification. Although valve calcification could be visualized either by echocardiography or coronary computed tomography, they only reflect the current burden of calcium deposit not the activity of calcium deposit. Limited studies exist regarding the usefulness of 18F-NaF uptake at aortic valve for prediction of stenosis progression.
Patients with moderate aortic stenosis - diagnosed by echocardiography - will be enrolled. Enrolled participants will undergo baseline 18F-NaF PET/CT within 6 weeks of baseline echocardiography and followed up for 1 year. After 1 year, all the participants are required to evaluate the aortic stenosis progression by performing echocardiography.
The objective of the study is to test whether baseline 18F-NaF uptake activity predict AS progression.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 20 years old
- •moderate aortic stenosis
排除标准
- •age < 20 yrs
- •pregnant women
结局指标
主要结局
mean PG
时间窗: AS severity progression after 1 year
次要结局
未报告次要终点
研究者
Ho-Joong Youn
Professor
Seoul St. Mary's Hospital