Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 18F-Fluoride activity
研究概览
简要总结
Structural valve dysfunction (SVD) is the most common and life threatening complication in patients treated by aortic valve replacement. A calcification process is frequently involved in SVD but its pathophysiology remains unclear. In the hypothesis of an active metabolic phenomenon of calcification, as previously shown in native aortic valve stenosis, rather than a passive deposit of calcium in valve tissue, positon emission tomography (PET) imaging with 18F-Fluoride could emphasize increased osteoblastic activity in SVD tissue.
This study will include patients with echocardiography-confirmed SVD. Echocardiographic parameters and other current parameters analyzed in SVD patients such as bioprosthesis calcium scoring derived from CT will be compared to 18F-Fluoride activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •age > 18
- •written informed consent
- •SVD defined on echocardiography by an alteration of bioprosthesis leaflets function with a mean transvalvular gradient > 20 mmHg and maximal velocity ≥ 3 m/s and effective orifice area ≤1.2 cm², and/or an aortic regurgitation more or equal to grade 2 on 4.
排除标准
- •Inability to give informed consent
- •Pregnancy
- •Concurrent antibiotherapy
- •Certain infectious endocarditis
- •Concurrent anti-inflammatory therapy, including corticosteroid therapy
结局指标
主要结局
18F-Fluoride activity
时间窗: The day of the inclusion
18F-Fluoride activity in valvular tissue will be determined by a tissue to bloodpool ratio of SUV (TBR). Patients will be divided in two groups : moderate SVD (EOA ≥ 0.8 and ≤ 1.2 cm²), and severe SVD (EOA ≤ 0.8 cm²), and TBR will be compared between the two groups, determined at time of inclusion.
次要结局
- Both 18F-Fluoride and 18F-FDG TBR correlation(6 months)
- TBR in 18F-FDG(6 months)