Biological Valve Prosthesis in Aortic Stenosis - Imaging, Biomarkers, Physical Performance and Patient Related Factors Predictive to Long-term Outcome (Bio-AS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Semiquantitative assessment of protein levels associated with myocardial performance
研究概览
简要总结
Patients with severe aortic stenosis accepted for transcatheter intervention or open surgery are included before the intervention, and then followed up with clinical visits during the first year after intervention. Imaging with echocardiography and computed tomography (CT) are performed together with additional imaging with magnetic resonance imaging (MRI) and Positron emissions tomography (PET)-CT in a subgroup of the study population. Blood samples, physical performance and questionnaires with focus on frailty and heart failure are also collected at each visit. A follow up with information of the outcomes after 2-5 years will be performed through national registries.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Accepted for aortic valve intervention
排除标准
- •No able to follow the study protocol
结局指标
主要结局
Semiquantitative assessment of protein levels associated with myocardial performance
时间窗: One year after intervention.
Level of normalized protein expression (NPX) in plasma, assessed by a multiplex proximity extension assay panel (Olink Bioscience, Uppsala, Sweden).
Imaging parameters associated with clinical outcome after intervention
时间窗: One year after intervention
Global longitudinal strain (%) of the right and left ventricle. The clinical outcome defined as a combination of mortality and hospitalization of heart failure
Semiquantitative assessment of protein levels associated with myocardial performance associated with clinical outcome after intervention
时间窗: Two years after intervention
Level of normalized protein expression (NPX) in plasma, assessed by a multiplex proximity extension assay panel (Olink Bioscience, Uppsala, Sweden). The clinical outcome defined as a combination of mortality and hospitalization for heart failure.
次要结局
- Imaging parameters associated with clinical outcome after intervention(Two years after intervention)