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

30 septembre 2021 mis à jour par: Centre Hospitalier Universitaire de Nice

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

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Anticipé)

540

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • France
      • Nice, France, 06000
        • Recrutement
        • Nice University Hospital
        • Contact:
        • Chercheur principal:
          • Emile Ferrari

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 99 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

all PE hospitalized for a pulmonary embolism

La description

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).

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Autre: AUCUNE INTERVENTION
AUCUNE INTERVENTION

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Chronic thrombo-embolic disease (CTED) prevalence
Délai: 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).
3 to 6 months after pulmonary embolism

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Associated risk factors for CTED occurrence
Délai: 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
3 to 6 months after pulmonary embolism
Associated risk factors for CTED occurrence BMI
Délai: 3 to 6 months after pulmonary embolism
The initial risk factors are the classic cardiologic data: BMI (kg / m²)
3 to 6 months after pulmonary embolism
Associated risk factors for CTED occurrence D-dimer level
Délai: 3 to 6 months after pulmonary embolism
The initial risk factors are the classic cardiologic data: D-dimer level (ng / ml) on arrival
3 to 6 months after pulmonary embolism
Associated risk factors for CTED occurrence clinical severity
Délai: 3 to 6 months after pulmonary embolism
The initial risk factors are the classic cardiologic data: clinical severity according to ESC criteria
3 to 6 months after pulmonary embolism
Associated risk factors for CTED occurrence ultrasound parameters of RV function
Délai: 3 to 6 months after pulmonary embolism
The initial risk factors are the classic cardiologic data: clinical severity: ultrasound parameters of RV function
3 to 6 months after pulmonary embolism
Associated risk factors for CTED occurrence diameter of the pulmonary artery trunk
Délai: 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
3 to 6 months after pulmonary embolism
Associated risk factors for CTED occurrence need for thrombolytic therapy or infusion of inotropic agent
Délai: 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
3 to 6 months after pulmonary embolism
Associated risk factors for CTED occurrence unprovoked nature of the event
Délai: 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
3 to 6 months after pulmonary embolism
Associated risk factors for CTED occurrence time between onset of symptoms and diagnosis
Délai: 3 to 6 months after pulmonary embolism
The initial risk factors are the classic cardiologic data: time between onset of symptoms and diagnosis (days)
3 to 6 months after pulmonary embolism
Associated risk factors (deep vein thrombosis ) for CTED prevalence
Délai: 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.
3 to 6 months after pulmonary embolism
Associated risk factors (new episode of PE or DVT ) for CTED occurrence
Délai: 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.
3 to 6 months after pulmonary embolism
Associated risk factors (clinical presumption of CTED ) for CTED occurrence
Délai: 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.
3 to 6 months after pulmonary embolism
quality of life score
Délai: 3 to 6 months after pulmonary embolism
Assessment of quality of life using the PembQOL score
3 to 6 months after pulmonary embolism

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Centre Hospitalier Universitaire de Nice

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2021

Achèvement primaire (Anticipé)

31 décembre 2025

Achèvement de l'étude (Anticipé)

31 décembre 2026

Dates d'inscription aux études

Première soumission

8 septembre 2021

Première soumission répondant aux critères de contrôle qualité

30 septembre 2021

Première publication (Réel)

11 octobre 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 octobre 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 septembre 2021

Dernière vérification

1 septembre 2021

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 21Cardio02

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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