Prevalence of Chronic Thromboembolic Pulmonary Hypertension After Acute Pulmonary Embolism. History of the Diagnosis. (Preva-CTEPH) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,003
- 试验地点
- 6
- 主要终点
- Cumulated incidence of CTEPH
研究概览
简要总结
The prevalence of chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary embolism (PE) varies widely (0.4% to 8.8%) in the literature. This large variation could be due to the inclusion of patients with pre-existing CTEPH revealed on the occasion of a recurrence of PE. However, the absence of hemodynamic data when diagnosing PE does not allow to distinguish these patients. A prospective multicentric study involving 146 patients showed that the majority of patients with CTEPH during follow-up had a pulmonary hypertension unknown at the time of PE diagnosis. It is necessary to confirm these results in a broader study.
The aim of this study is to evaluate the cumulative incidence of CTEPH after a PE.
详细描述
The patients selected in this study are patients with an objectively confirmed PE and previously included since at least 12 months in one of the studies of the INNOVTE network.
Patients who are alive at the time of the selection for the PREVA-CTEPH study are contacted by phone or by mail for inclusion in the prospective interventional part of the PREVA-CTEPH study. Patients who consent to participate to this prospective interventional phase of the PREVA-CTEPH study have dyspnea assessment, EKG, and echocardiography to investigate the diagnosis of CTEPH. Patients with dyspnea (NYHA >1) and/or a high or intermediate echocardiographic probability of pulmonary hypertension (ESC criteria) have a V/Q lung scan, a right heart catheterization and a pulmonary angiography to objectively confirm the diagnosis of CTEPH according to the current ESC guidelines.
Retrospective phase: All clinical (dyspnea, signs of right ventricular insufficiency...), echocardiographic and imaging (pulmonary angiography, V/Q lung scan) relevant data after the diagnosis of index PE are retrieved from the clinical chart of each patients alive at the time of the selection for the PREVA-CTEPH study and/or with a diagnosis of CTEPH confirmed after the diagnosis of index PE and/or if the patient don't consent to participate to the prospective interventional phase.
For patients died between the inclusion in one of the studies of the INNOVTE network and the time of the selection for the PREVA-CTEPH study, the date and the cause of death are recorded. The same data of the retrospective phase are retrieved.
All cases of CTEPH are adjudicated by an independent committee. In this case, initial Imaging data (CT pulmonary angiography and echocardiography) performed at the time of index PE diagnosis are retrieved for searching previous sign of CTEPH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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 older than 18 years
- •Pulmonary embolism objectively confirmed
- •Treated during at least 3 months with curative anticoagulant
- •Previously included since at least 1 year in one of the studies of the INNOVTE network
- •affiliated to the national social security
- •after written informed consent
排除标准
- •Patients with an objectively confirmed CTEPH before the diagnosis of index PE
- •Follow-up impossible
结局指标
主要结局
Cumulated incidence of CTEPH
时间窗: 30-day +/- 15 days after inclusion visit
Cumulated incidence rate of CTEPH after pulmonary embolism
次要结局
- Risk factors of CTEPH(30-day +/- 15 days after inclusion visit)
- Cumulated incidence of CTEPH in patients without previous signs of CTEPH at the time of index PE diagnosis(30-day +/- 15 days after inclusion visit)
- Cumulated incidence of CTEPH in patients with previous signs of CTEPH at the time of index PE diagnosis(30-day +/- 15 days after inclusion visit)
- Complications associated with right heart catheterization(30-day +/- 15 days after inclusion visit)
- Complications associated with pulmonary angiography(30-day +/- 15 days after inclusion visit)