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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pulmonary embolism | Patients with a recent pulmonary embolism event will be followed for 6 months and will benefit of routine tests (Lung scintigraphy, venous echo doppler, d- dimers measurement) in order to determine chronic thrombo-embolic disease prevalence and its risk factors. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NO INTERVENTION | Other | NO INTERVENTION |
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| Measure | Description | Time Frame |
|---|---|---|
| Chronic thrombo-embolic disease (CTED) prevalence | 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). | 3 to 6 months after pulmonary embolism |
| Measure | Description | Time Frame |
|---|---|---|
| Associated risk factors for CTED occurrence | The initial risk factors are the classic cardiologic data: (age, BMI, D-dimer level, clinical severity-PESI score, diameter of the right ventricle on ultrasound (mm), quality ofsystolic function right ventricle on ultrasound, thrombolytic treatment, size of the pulmonary artery trunk, unprovoked nature of VTE, time between onset of symptoms and diagnosis) global clinical Data in the medical document |
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Inclusion Criteria:
Exclusion Criteria:
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all PE hospitalized for a pulmonary embolism
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nice University Hospital | Nice | 06000 | France |
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| 3 to 6 months after pulmonary embolism |
| Associated risk factors for CTED occurrence BMI | The initial risk factors are the classic cardiologic data: BMI (kg / m²) | 3 to 6 months after pulmonary embolism |
| Associated risk factors for CTED occurrence D-dimer level | The initial risk factors are the classic cardiologic data: D-dimer level (ng / ml) on arrival | 3 to 6 months after pulmonary embolism |
| Associated risk factors for CTED occurrence clinical severity | The initial risk factors are the classic cardiologic data: clinical severity according to ESC criteria | 3 to 6 months after pulmonary embolism |
| Associated risk factors for CTED occurrence ultrasound parameters of RV function | The initial risk factors are the classic cardiologic data: clinical severity: ultrasound parameters of RV function | 3 to 6 months after pulmonary embolism |
| Associated risk factors for CTED occurrence diameter of the pulmonary artery trunk | The initial risk factors are the classic cardiologic data: clinical severity: diameter of the pulmonary artery trunk (mm) measured on ultrasound and / or CT scan | 3 to 6 months after pulmonary embolism |
| Associated risk factors for CTED occurrence need for thrombolytic therapy or infusion of inotropic agent | The initial risk factors are the classic cardiologic data: clinical severity: need for thrombolytic therapy or infusion of inotropic agent at the physician's discretion | 3 to 6 months after pulmonary embolism |
| Associated risk factors for CTED occurrence unprovoked nature of the event | The initial risk factors are the classic cardiologic data: clinical severity: unprovoked nature of the event at the physician's discretion | 3 to 6 months after pulmonary embolism |
| Associated risk factors for CTED occurrence time between onset of symptoms and diagnosis | The initial risk factors are the classic cardiologic data: time between onset of symptoms and diagnosis (days) | 3 to 6 months after pulmonary embolism |
| Associated risk factors (deep vein thrombosis ) for CTED prevalence | Number of patient with a persistence of a DVT and the persistence of deep vein thrombosis (The persistence of DVT being defined by the presence of a venous thrombus of the same location as that of the initial episode) Measurement of the level of CTED according to the persistence of deep vein thrombosis beyond diagnosis. The persistence of a DVT is defined by the presence at 3 or 6 months of a venous thrombus of the same location as the initial episode, among the patients who presented with a PE associated with a DVT. | 3 to 6 months after pulmonary embolism |
| Associated risk factors (new episode of PE or DVT ) for CTED occurrence | Number of patients (with or without CTED) with a recurrence (new episode of PE or DVT) Recurrence of VTE is defined by defined by a new documented thromboembolic event with a non-normal d-dimers level. | 3 to 6 months after pulmonary embolism |
| Associated risk factors (clinical presumption of CTED ) for CTED occurrence | Agreement between the clinical presumption of CTED by an experienced physician (questioning and evaluation of dyspnea) compared to the diagnosis of CTED by lung scintigraphy. The clinical presumption by the clinician (presence or not of an CTED) is based on the questioning, the clinical examination and the realization of an echocardiography, if necessary, in order to rule out pulmonary hypertension. | 3 to 6 months after pulmonary embolism |
| quality of life score | Assessment of quality of life using the PembQOL score | 3 to 6 months after pulmonary embolism |