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

Last updated: March 5, 2025
Sponsor: Centre Hospitalier Universitaire de Nice
Overall Status: Completed

Phase

N/A

Condition

Blood Clots

Circulation Disorders

Claudication

Treatment

NO INTERVENTION

Clinical Study ID

NCT05073666
21Cardio02
  • Ages 18-99
  • All Genders

Study 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

Inclusion Criteria:

  • definite PE with expected life expectancy of more than 3 months - Age ≥ 18 yearsold.

  • Patients with a first episode of symptomatic pulmonary embolism, diagnosed by CTangiography or pulmonary scintigraphy and treated in a conventional manner.

  • Having received oral information about the study and having expressed anon-opposition to participate to the study

  • Benefiting from a social security scheme

Exclusion

Exclusion Criteria:

  • Patients with pulmonary hypertension.

  • Patients who have already had a recurrence of pulmonary embolism or deep veinthrombosis of the lower limbs.

  • Patients with a contraindication to performing a lung ventilation-perfusionscintigraphy.

  • Patients at high risk of recurrence of venous thromboembolic disease (severethrombophilia 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 thrombosisdiagnosed by venous Doppler ultrasound of the lower limbs within the first 3 or 6months depending on the nature of the VTE.

  • Occurence of pulmonary hypertension detected by trans-thoracic ultrasound (systolicpulmonary arterial pressure more than 35 mmgh).

Study Design

Total Participants: 123
Treatment Group(s): 1
Primary Treatment: NO INTERVENTION
Phase:
Study Start date:
January 01, 2021
Estimated Completion Date:
February 03, 2023

Connect with a study center

  • Nice University Hospital

    Nice, 06000
    France

    Site Not Available

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