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Completed

NCT Number: NCT05073666

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

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.

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Key information

Conditions

Chronic Emboilism

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nice University Hospital

Nice, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

No intervention

Other

NO INTERVENTION

Primary outcomes

  1. 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

  1. Associated risk factors for CTED occurrence

    Time frame: 3 to 6 months after pulmonary embolism

    The initial risk factors are the classic cardiologic data: (age, BMI, D-dimer level, clinical severity-PESI score, diameter of the right ventricle on ultrasound (mm), quality ofsystolic function right ventricle on ultrasound, thrombolytic treatment, size of the pulmonary artery trunk, unprovoked nature of VTE, time between onset of symptoms and diagnosis) global clinical Data in the medical document

  2. Associated risk factors for CTED occurrence BMI

    Time frame: 3 to 6 months after pulmonary embolism

    The initial risk factors are the classic cardiologic data: BMI (kg / m²)

  3. Associated risk factors for CTED occurrence D-dimer level

    Time frame: 3 to 6 months after pulmonary embolism

    The initial risk factors are the classic cardiologic data: D-dimer level (ng / ml) on arrival

  4. Associated risk factors for CTED occurrence clinical severity

    Time frame: 3 to 6 months after pulmonary embolism

    The initial risk factors are the classic cardiologic data: clinical severity according to ESC criteria

  5. Associated risk factors for CTED occurrence ultrasound parameters of RV function

    Time frame: 3 to 6 months after pulmonary embolism

    The initial risk factors are the classic cardiologic data: clinical severity: ultrasound parameters of RV function

  6. Associated risk factors for CTED occurrence diameter of the pulmonary artery trunk

    Time frame: 3 to 6 months after pulmonary embolism

    The initial risk factors are the classic cardiologic data: clinical severity: diameter of the pulmonary artery trunk (mm) measured on ultrasound and / or CT scan

  7. Associated risk factors for CTED occurrence need for thrombolytic therapy or infusion of inotropic agent

    Time frame: 3 to 6 months after pulmonary embolism

    The initial risk factors are the classic cardiologic data: clinical severity: need for thrombolytic therapy or infusion of inotropic agent at the physician's discretion

  8. Associated risk factors for CTED occurrence unprovoked nature of the event

    Time frame: 3 to 6 months after pulmonary embolism

    The initial risk factors are the classic cardiologic data: clinical severity: unprovoked nature of the event at the physician's discretion

  9. Associated risk factors for CTED occurrence time between onset of symptoms and diagnosis

    Time frame: 3 to 6 months after pulmonary embolism

    The initial risk factors are the classic cardiologic data: time between onset of symptoms and diagnosis (days)

  10. Associated risk factors (deep vein thrombosis ) for CTED prevalence

    Time frame: 3 to 6 months after pulmonary embolism

    Number of patient with a persistence of a DVT and the persistence of deep vein thrombosis (The persistence of DVT being defined by the presence of a venous thrombus of the same location as that of the initial episode)

    Measurement of the level of CTED according to the persistence of deep vein thrombosis beyond diagnosis. The persistence of a DVT is defined by the presence at 3 or 6 months of a venous thrombus of the same location as the initial episode, among the patients who presented with a PE associated with a DVT.

  11. Associated risk factors (new episode of PE or DVT ) for CTED occurrence

    Time frame: 3 to 6 months after pulmonary embolism

    Number of patients (with or without CTED) with a recurrence (new episode of PE or DVT) Recurrence of VTE is defined by defined by a new documented thromboembolic event with a non-normal d-dimers level.

  12. Associated risk factors (clinical presumption of CTED ) for CTED occurrence

    Time frame: 3 to 6 months after pulmonary embolism

    Agreement between the clinical presumption of CTED by an experienced physician (questioning and evaluation of dyspnea) compared to the diagnosis of CTED by lung scintigraphy. The clinical presumption by the clinician (presence or not of an CTED) is based on the questioning, the clinical examination and the realization of an echocardiography, if necessary, in order to rule out pulmonary hypertension.

  13. quality of life score

    Time frame: 3 to 6 months after pulmonary embolism

    Assessment of quality of life using the PembQOL score

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: PACTE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 11, 2021
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.