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临床试验/NCT01781858
NCT01781858已完成不适用

Study on the Clinical Course Of Pulmonary Embolism

University of Padova0 个研究点目标入组 700 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
700
主要终点
Incidence of chronic thromboembolic pulmonary hypertension

研究概览

简要总结

The course of both pulmonary embolism (PE) and one of its more relevant late complications, i.e. chronic thromboembolic pulmonary hypertension (CTEPH) is still substantially unknown.

Recent evidence has shown that the incidence of CTEPH is higher than previously believed, but this has not been confirmed by other studies. A clear link between PE and CTEPH has been questioned by some experts. A great number of patients affected by PE persistently have residual chronic thromboembolic material the meaning of which is a matter of debate. The evidence sustaining a link between chronic residual PE and subsequent PE recurrences or CTEPH is insufficient.

Thus, a nationwide, multicentre, prospective cohort study was designed with the following aims:

  1. to ascertain the incidence of symptomatic CTEPH after a first episode of acute PE;
  2. to ascertain the incidence of venous thromboembolic (VTE) recurrences after a first episode of acute PE;
  3. to evaluate whether a relation exists between chronic residual PE and CTEPH
  4. to evaluate whether a relation exists between chronic residual PE and VTE recurrences;
  5. to evaluate whether a relation exists between persistent right ventricular dysfunction and CTEPH;
  6. to evaluate whether a relation exists between persistent right ventricular dysfunction and PE recurrences.

For each enrolling centre, consecutive outpatients or inpatients with an objectively diagnosed first acute PE episode are considered eligible.

详细描述

All patients enrolled in the study received a diagnosis of PE by means of chest CT scan, lung scanning or pulmonary angiography. All patients should undergo an echocardiographic examination during the acute phase of PE, when this is possible. All patients will be treated according to current international guidelines and local protocols. All surviving patients will receive an echocardiographic examination after 6 weeks and 6 months. All surviving patients will receive a perfusional pulmonary scintigraphy at 6 months and be subsequently followed up every 6 months for at least 3 years.

In case of clinical suspicion of VTE recurrence a diagnostic procedure will be performed in order to confirm the recurrent VTE episode ( Chest CT scan, lung scan, Pulmonary angiography, compressive ultrasound, phlebography, vein CT scan).

In case of clinical suspicion of CTEPH, a further diagnostic workup will be performed, consisting in echocardiography, ventilation/perfusion lung scanning, multidetector chest CT scanning, and pulmonary angiography, with direct measurement of the pulmonary-artery pressure.

The extension of pulmonary embolism during the acute phase will be graded according to a standardized scoring system by local investigators while the extension of chronic residual pulmonary embolism will be graded according to a standardized scoring system ( Meyer score) by both local investigators and an independent committee. All outcome events will be centrally adjudicated by an independent committee.

All clinical data ( initial data on medical history, clinical symptoms, presence of risk factors, diagnoses, diagnostic tests results, treatment type and duration, outcome events and other) will be collected by the local investigators in an electronic medical database. Related data will be sent to the coordinating centre on a regular basis. All recruiting centres will be regularly monitored by the coordinating Centre.

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

入选标准

  • Consecutive Outpatients/Inpatients with acute first episode of acute pulmonary embolism

排除标准

  • Pregnancy
  • Age < 18 years
  • expected survival < 2 years
  • previous episodes of VTE
  • need for anticoagulation for reasons other than VTE
  • preexisting severe cardiac or pulmonary diseases
  • preexisting diseases that could cause non thromboembolic pulmonary hypertension
  • Patients geographically inaccessible for follow up
  • Low compliance to anticoagulant therapy and planned diagnostic work-up
  • Refusal to give written informed consent

结局指标

主要结局

Incidence of chronic thromboembolic pulmonary hypertension

时间窗: within 3 years

次要结局

  • Incidence of recurrent venous thromboembolic events(within 3 years)

研究者

发起方
University of Padova
申办方类型
Other
责任方
Principal Investigator
主要研究者

Raffaele Pesavento

MD

University of Padova

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