The Role of Endothelial Function Test in Risk Stratification for Early and Late Complications After Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- Post PE complications
研究概览
简要总结
The aim of this study is to investigate the association between endothelial dysfunction, measured by RHI as assessed by the peripheral arterial tonometry method, and PE complications defined as re-event of PE or DVT, systemic embolism or all-cause mortality
详细描述
200 Patients will be identified through routine daily scanning of imaging records (CT, Echocardiography) for patients diagnosed with PE. Presenting signs and symptoms as well as clinical and imaging findings during the initial presentation and hospitalization will be incorporated into a computerized pre-specified electronic CRF. During hospitalization, an endothelial function test will be performed 48 hours post admission. A trained technician will perform the test using the EndoPAT device in order to assess patient RHI, a score less than 1.67 will be considerate as endothelial dysfunction. Patients will then be followed for pre-specified clinical events of up to 1 year post discharge and especially the development of chronic thromboembolic pulmonary disease, post thrombotic syndrome and clinical events. RHI will be assessed during 1-year follow up visit.
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
- •Age >18 years old
- •Patient is hospitalized with the diagnosis of acute PE
- •Clinically stable patients.
- •Clinical diagnosis of PE based on CT scan or nuclear imaging.
- •Willing and able to sign informed consent
排除标准
- •Previous myocardial infarction during the last 3 months.
- •Planned surgery or PCI.
- •Inability to perform endothelial function test.
- •Current participation in clinical trial.
- •Substrate or drug abuse or alcohol consumption.
结局指标
主要结局
Post PE complications
时间窗: 2 years
The aim of this study is to investigate the association between endothelial dysfunction, measured by RHI as assessed by the peripheral arterial tonometry method, and PE complications defined as re-event of PE or DVT, systemic embolism or all-cause mortality
次要结局
- HRV(2 years)
- Biochemistry(2 years)
- Augmentation Index (AI)(2 years)
研究者
Dr. Shlomi Matetzky
Director , Cardiac Intensive Care Unit
Sheba Medical Center