Research Interest Antiphospholipid in Predicting Embolic Risk During Infective Endocarditis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- Symptomatic or asymptomatic events occurring before and after IE diagnosis
研究概览
简要总结
EMBOL-EI (Research Interest antiphospholipid antibody for embolic risk prediction in infective endocarditis) is a prospective cohort study with a biological collection.
The main objective is: to re-evaluate the potential value of antiphospholipid (aPL) antibodies as predictors of embolic events in infective endocarditis (IE) in the light of the improved current knowledge on these aPL.
The seconds objectives are: Other plasma biomarkers of hemostasis (coagulation activation markers: D-dimer fragment 1 + 2 of prothrombin; endothelial biomarkers: plasma levels of von Willebrand factor) will be taken into account in the analysis, and interest in predicting embolic risk, alone or in combination with aPL will be investigated.
详细描述
Criteria of inclusion
- Patient hospitalized in the University Hospital of Nancy with an Endocarditis some as modified Duke criteria by Li.
The patient is eligible if it is considered and treated as a case of infective endocarditis by physicians ensuring its management. The application of the diagnostic classification Duke criteria modified by Li is made after the collection of all the data at the output of the patient. Will be retained for the analysis of patients meeting certain infective endocarditis.
Clinical, microbiological data, derived from complementary therapies and scalable examinations (including the endpoint) were collected during the hospital stay by doctors that support helped a patient technician clinical studies. Each application is reviewed by a multidisciplinary panel of two experts for validation.
Once validated record, the data collection schedule is sent to the Centre d'Investigation Clinique 1433 Epidémiologie Clinique (CIC-EC) to be entered on a database.
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
- •All the patients admitted either in the Infectious Department, in the Cardiology Department or in the Intensive Care Unit of the University Hospital of Nancy and treated for IE.
排除标准
- •Patients with a previously known aPL syndrome or illness frequently associated with aPL syndrome (such as lupus)
- •Patients with a delay between blood sample and diagnosis of IE longer than 21days
- •Patients who had no symptomatic embolic events and no imaging procedure to detect an asymptomatic embolic event
结局指标
主要结局
Symptomatic or asymptomatic events occurring before and after IE diagnosis
时间窗: at discharge, an average of 8 weeks after inclusion
By patients have systematic extra-cardiac imaging
次要结局
未报告次要终点
研究者
Christine Selton-Suty
Dr
Central Hospital, Nancy, France