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

30 september 2021 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Förväntat)

540

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Frankrike
      • Nice, Frankrike, 06000
        • Rekrytering
        • Nice University Hospital
        • Kontakt:
        • Huvudutredare:
          • Emile Ferrari

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 99 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

all PE hospitalized for a pulmonary embolism

Beskrivning

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).

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Övrig: INGA INVÄNDNING
INGA INVÄNDNING

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Chronic thrombo-embolic disease (CTED) prevalence
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Associated risk factors for CTED occurrence
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 3 to 6 months after pulmonary embolism
Assessment of quality of life using the PembQOL score
3 to 6 months after pulmonary embolism

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Centre Hospitalier Universitaire de Nice

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2021

Primärt slutförande (Förväntat)

31 december 2025

Avslutad studie (Förväntat)

31 december 2026

Studieregistreringsdatum

Först inskickad

8 september 2021

Först inskickad som uppfyllde QC-kriterierna

30 september 2021

Första postat (Faktisk)

11 oktober 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 oktober 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 september 2021

Senast verifierad

1 september 2021

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 21Cardio02

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