Prospective Cohort Study of Patients With Infective Endocarditis Admitted at Cardiology Institute of Pitié-Salpêtrière Hospital
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- All-cause in hospital mortality
研究概览
简要总结
Infective endocarditis (IE) is a severe condition associated with high mortality. Due to the relative low prevalence of IE, prospective data are lacking and current guidelines are mostly based on expert consensus with low level of evidence. IE is also associated with severe complications especially strokes that occur in about one third of the patients.
In order to improve the management and the prognosis of IE, clinical data from larges prospective cohort studies are needed.
详细描述
The study will take place at the Cardiology institute of the Pitié-Salpêtrière hospital. All patients referred to this tertiary care center for IE management will be included.
The characteristics of the patients (demographics, clinical, laboratory, and imaging data) at the time of IE diagnosis and during the follow-up will be collected. The patients will be followed up to 10 years after inclusion.
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
- •Patients with confirmed IE according to European Society of Cardiology criteria
排除标准
- •Opposition of the patient to participate
结局指标
主要结局
All-cause in hospital mortality
时间窗: up to 90 days
All-cause mortality during the length of hospital stay
次要结局
- symptomatic or asymptomatic systemic embolism(up to 90 days after inclusion)
- Association between coagulation biomarkers (D-dimer, fibrin monomer, circulating anticoagulant, von Willebrandt factor (VWF) antigen level, von Willebrandt factor (VWF) activity) assessed at the inclusion and the presence of systemic embolism(up to 90 days after inclusion)
- heart failure, intracranial hemorrhage, or false vascular aneurysm during hospitalization(up to 90 days after inclusion)
- All-cause mortality(an average of 10 years)
- composite criteria of stroke, Intracranial hemorrhage, hospitalization due to cardiovascular cause or IE recurrence(through study completion, an average of 10 years)
- Occurrence of contrast-associated acute kidney injury during the length of hospital stay(up to 90 days after inclusion)
- Stroke(90 days after inclusion)
- Association between occurrence of systemic embolism and the composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score ≥ 3(1 year after inclusion)
- composite criteria of all-cause mortality, stroke or intracranial hemorrhage, severe hemorrhage as defined by BARC score ≥ 3(through study completion, an average of 10 years)