Prevalence and Risk Factors of Chronic Thrombo-embolic Disease After a Pulmonary Embolism Event The PACTE Registry

Centre Hospitalier Universitaire de Nice1 site in 1 country123 target enrollmentJanuary 1, 2021

ConditionsChronic Emboilism

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Emboilism
Sponsor: Centre Hospitalier Universitaire de Nice
Enrollment: 123
Locations: 1
Primary Endpoint: Chronic thrombo-embolic disease (CTED) prevalence
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2021

End Date

February 3, 2023

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Nice

Responsible Party

Sponsor

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).

Outcomes

Primary Outcomes

Chronic thrombo-embolic disease (CTED) prevalence

Time Frame: 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).

Secondary Outcomes

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)