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

NCT ID: NCT05073666

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 123 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-02-03

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.

Conditions

Chronic Emboilism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

NO INTERVENTION

Intervention Type: OTHER

NO INTERVENTION

Interventions

NO INTERVENTION

NO INTERVENTION

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nice University Hospital

Nice, , France

Countries

France

Other Identifiers

21Cardio02

Identifier Type: -

Identifier Source: org_study_id