Clinical trial NCT05073666: Prevalence and Risk Factors of Chronic Thrombo-embolic Disease After a Pulmonary Embolism Event
Official title: Prevalence and Risk Factors of Chronic Thrombo-embolic Disease After a Pulmonary Embolism Event The PACTE Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Emboilism
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-10-11
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all PE hospitalized for a pulmonary embolism

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Chronic thrombo-embolic disease (CTED) prevalence
timeFrame: 3 to 6 months after pulmonary embolism
Secondary outcomes:
measure: Associated risk factors for CTED occurrence
timeFrame: 3 to 6 months after pulmonary embolism
measure: Associated risk factors for CTED occurrence BMI
timeFrame: 3 to 6 months after pulmonary embolism
measure: Associated risk factors for CTED occurrence D-dimer level
timeFrame: 3 to 6 months after pulmonary embolism
measure: Associated risk factors for CTED occurrence clinical severity
timeFrame: 3 to 6 months after pulmonary embolism
measure: Associated risk factors for CTED occurrence ultrasound parameters of RV function
timeFrame: 3 to 6 months after pulmonary embolism
measure: Associated risk factors for CTED occurrence diameter of the pulmonary artery trunk
timeFrame: 3 to 6 months after pulmonary embolism
measure: Associated risk factors for CTED occurrence need for thrombolytic therapy or infusion of inotropic agent
timeFrame: 3 to 6 months after pulmonary embolism
measure: Associated risk factors for CTED occurrence unprovoked nature of the event
timeFrame: 3 to 6 months after pulmonary embolism
measure: Associated risk factors for CTED occurrence time between onset of symptoms and diagnosis
timeFrame: 3 to 6 months after pulmonary embolism
measure: Associated risk factors (deep vein thrombosis ) for CTED prevalence
timeFrame: 3 to 6 months after pulmonary embolism
measure: Associated risk factors (new episode of PE or DVT ) for CTED occurrence
timeFrame: 3 to 6 months after pulmonary embolism
measure: Associated risk factors (clinical presumption of CTED ) for CTED occurrence
timeFrame: 3 to 6 months after pulmonary embolism
measure: quality of life score
timeFrame: 3 to 6 months after pulmonary embolism
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References: