Stratifying Clinical Risk in Patients With Atrial Fibrillation and Chronic Kidney Disease by Studying How Abnormalities in Clot Structure/Function and Lipoproteins Contribute to Thrombosis and Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- WP1: Fibrin clot structure and function assessment using validated turbidity and fibrinolysis test
研究概览
简要总结
This study is designed to investigate the role of lipids/lipoproteins as a potential cause for the harmful changes seen in fibrin clot properties with renal dysfunction and atrial fibrillation
详细描述
This is a prospective, observational, blinded study that will be conducted in two parts. The first study will assess the relationship between lipids/lipoproteins and fibrin clot properties among anticoagulated atrial fibrillation patients with and without renal dysfunction. The second study will assess the effects of statin therapy on lipids/lipoproteins and fibrin clot properties in anticoagulated atrial fibrillation patients with renal dysfunction. Renal dysfunction is defined as an estimated glomerular filtration rate below 50 ml/min/1.73m2 for the purposes for this trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
WP2: AF + CKD
Anticoagulated participants with atrial fibrillation and chronic kidney disease, and are commencing statin therapy
干预措施: Statin (Drug)
结局指标
主要结局
WP1: Fibrin clot structure and function assessment using validated turbidity and fibrinolysis test
时间窗: At baseline
Lag time, maximum absorbance, time to maximum absorbance and clot lysis time
WP2: Oxidised low density lipoprotein
时间窗: At baseline and after 6 weeks of statin
Measure of oxidised low density lipoprotein
WP2: Fibrin permeation analysis using validated test
时间窗: At baseline and after 6 weeks of statin
Permeation constant (Ks)
WP2: Low density lipoprotein fractions
时间窗: At baseline and after 6 weeks of statin
Measure of low density lipoprotein subclass fractions
WP1: Low density lipoprotein fractions
时间窗: At baseline
Measure of low density lipoprotein subclass fractions
WP1: Fibrin permeation analysis using validated test
时间窗: At baseline
Permeation constant (Ks)
WP1: Oxidised low density lipoprotein
时间窗: At baseline
Measure of oxidised low density lipoprotein
WP2: Fibrin clot structure and function assessment using validated turbidity and fibrinolysis test
时间窗: At baseline and after 6 weeks of statin therapy
Lag time, maximum absorbance, time to maximum absorbance and clot lysis time
次要结局
- WP1: Scanning electron microscopy(At baseline)
研究者
Wern Yew Ding
Clinical Research Fellow
University of Liverpool