Response of Intracardiac Thrombus to Anticoagulants in Patients With Non-valvular Atrial Fibrillation (LYSIS): an Investigator-initiated, National, Multicenter, Retrospective-prospective, Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Success rate of thrombolysis
研究概览
简要总结
This study aims to analyze changes in the immune status, metabolic status, and host microbiome community structure in non-valvular atrial fibrillation patients with intracardiac thrombus. Additionally, the study aims to analyze factors that influence the responsiveness and occurrence of adverse events related to anticoagulant therapy.
详细描述
The researcher-initiated clinical cohort study is a national multicenter, retrospective-prospective study of non-valvular atrial fibrillation patients with intracardiac thrombus, based on molecular biology and multi-omics analysis. The study aims to analyze the changes in the body's immune status, metabolic status, and host microbiome community structure, as well as to analyze the factors that influence the responsiveness of intracardiac thrombus to anticoagulant therapy. The study also evaluates the occurrence of adverse events related to anticoagulation in these patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old, age ≤80 years old
- •Patients with atrial fibrillation detected by routine surface 12-lead electrocardiography or Holter
- •Transesophageal echocardiography confirmed the presence of cardiac thrombus, and the patient had not received any anticoagulant therapy
排除标准
- •Echocardiography confirmed valvular heart disease
- •Contraindications to anticoagulants
- •Patients with the previous history of hemorrhagic stroke
- •Low platelet count or functional platelet defects
- •Congenital or acquired coagulation or bleeding disorders
- •Abnormal liver function (liver enzymes >2 times the upper limit)
- •Renal failure (endogenous creatinine clearance <30ml/min)
- •Surgery was planned within the intended study time or had been operated within 30 days before the study
- •Other comorbidities that can cause bleeding, such as tumors
- •Patients with autoimmune diseases or immunodeficiency, or patients who are currently using immunosuppressants and immunomodulators
- •Patients are currently participating in other clinical studies
结局指标
主要结局
Success rate of thrombolysis
时间窗: 1，2，3 months after enrollment.
Success rate of thrombolysis within 3 months after initiating anticoagulation therapy.
Change of incidence of MACCE
时间窗: 1，2，3 months after enrollment.
Major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, myocardial infarction, coronary revascularization, and stroke.
次要结局
- Change of incidence of all-cause mortality(1，2，3 months after enrollment.)
- Change of incidence of myocardial infarction(1，2，3 months after enrollment.)
- Change of incidence of stroke(1，2，3 months after enrollment.)
- Change of incidence of adverse anticoagulation events(1，2，3 months after enrollment.)
- Change of incidence of coronary revascularization(1，2，3 months after enrollment.)