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

Centre Hospitalier Universitaire de Nice

Status: Completed

Conditions: Chronic Emboilism

Treatments: Other: NO INTERVENTION

Study type: Observational

Funder types: Other

Identifiers

NCT05073666

21Cardio02

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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).

Trial design

123 participants in 1 patient group

pulmonary embolism

Description:

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.

Treatment:

Other: NO INTERVENTION