NCT05073666已完成不适用
Prevalence and Risk Factors of Chronic Thrombo-embolic Disease After a Pulmonary Embolism Event The PACTE Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Chronic thrombo-embolic disease (CTED) prevalence
研究概览
简要总结
Venous thromboembolic disease (VTE) is a common clinical entity whose two manifestations are deep vein thrombosis (DVT) and pulmonary embolism (PE). After an acute PE, almost half of the patients complain residual dyspnea, despite well-conducted curative anticoagulation. Some will present persistent defects on lung scan-scintigraphy, without pulmonary hypertension. This condition defines Chronic-Thrombo-Embolic Disease(CTED). The prevalence of CTED after PE is poorly known as are its risk factors.
The primary objective is to determine the prevalence of CTED at 3 or 6 months, depending on the provoked or unprovoked character, after a PE.
The secondary objectives are:
- To determine the potential risk factors for the occurrence of CTED.
- To look for an association between the persistence of DVT and the occurrence of CTED.
- To look for an association between the diagnosis of CTED and PE recurrence during the 12-month follow-up.
- To determine the diagnostic performance of the clinician alone compared to the lung scintigraphy (gold standard) for the diagnosis of CTED.
- To compare the impact on the quality of life (QoL) with or without CTED.
- To determine the correlation between impaired QoL and the degree of residual obstruction on lung scintigraphy.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •definite PE with expected life expectancy of more than 3 months - Age ≥ 18 years old.
- •Patients with a first episode of symptomatic pulmonary embolism, diagnosed by CT angiography or pulmonary scintigraphy and treated in a conventional manner.
- •Having received oral information about the study and having expressed a non-opposition to participate to the study
- •Benefiting from a social security scheme
排除标准
- •Patients with pulmonary hypertension.
- •Patients who have already had a recurrence of pulmonary embolism or deep vein thrombosis of the lower limbs.
- •Patients with a contraindication to performing a lung ventilation-perfusion scintigraphy.
- •Patients at high risk of recurrence of venous thromboembolic disease (severe thrombophilia or active cancer).
- •Classical contraindications to anticoagulants.
- •Vulnerable patients: pregnant women, under guardianship or curatorship
- •Premature termination of participation
- •Recurrent pulmonary embolism diagnosed by CT angiography, or deep vein thrombosis diagnosed by venous Doppler ultrasound of the lower limbs within the first 3 or 6 months depending on the nature of the VTE.
- •Occurence of pulmonary hypertension detected by trans-thoracic ultrasound (systolic pulmonary arterial pressure more than 35 mmgh).
结局指标
主要结局
Chronic thrombo-embolic disease (CTED) prevalence
时间窗: 3 to 6 months after pulmonary embolism
CTED is determined by lung ventilation-perfusion scintigraphy witch detect a persistant obstruction more than 10% of the pulmonary arteries perfusion (defined by amputation of at least two pulmonary segments on V/ Q lung scan).
次要结局
- quality of life score(3 to 6 months after pulmonary embolism)
- Associated risk factors for CTED occurrence BMI(3 to 6 months after pulmonary embolism)
- Associated risk factors for CTED occurrence D-dimer level(3 to 6 months after pulmonary embolism)
- Associated risk factors for CTED occurrence ultrasound parameters of RV function(3 to 6 months after pulmonary embolism)
- Associated risk factors (deep vein thrombosis ) for CTED prevalence(3 to 6 months after pulmonary embolism)
- Associated risk factors (new episode of PE or DVT ) for CTED occurrence(3 to 6 months after pulmonary embolism)
- Associated risk factors for CTED occurrence(3 to 6 months after pulmonary embolism)
- Associated risk factors for CTED occurrence clinical severity(3 to 6 months after pulmonary embolism)
- Associated risk factors (clinical presumption of CTED ) for CTED occurrence(3 to 6 months after pulmonary embolism)
- Associated risk factors for CTED occurrence diameter of the pulmonary artery trunk(3 to 6 months after pulmonary embolism)
- Associated risk factors for CTED occurrence need for thrombolytic therapy or infusion of inotropic agent(3 to 6 months after pulmonary embolism)
- Associated risk factors for CTED occurrence unprovoked nature of the event(3 to 6 months after pulmonary embolism)
- Associated risk factors for CTED occurrence time between onset of symptoms and diagnosis(3 to 6 months after pulmonary embolism)
研究者
研究点 (1)
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