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

NCT05073666 | Completed

• 1 other identifier: 21Cardio02
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Chronic thrombo-embolic disease (CTED) prevalence

  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

Secondary Outcomes (13)

• Associated risk factors for CTED occurrence

  3 to 6 months after pulmonary embolism

• Associated risk factors for CTED occurrence BMI

  3 to 6 months after pulmonary embolism

• Associated risk factors for CTED occurrence D-dimer level

  3 to 6 months after pulmonary embolism

• Associated risk factors for CTED occurrence clinical severity

  3 to 6 months after pulmonary embolism

• Associated risk factors for CTED occurrence ultrasound parameters of RV function

  3 to 6 months after pulmonary embolism

Study Arms (1)

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.

Other: NO INTERVENTION

Interventions

NO INTERVENTION OTHER

NO INTERVENTION

pulmonary embolism

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all PE hospitalized for a pulmonary embolism

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Nice University Hospital

Nice, 06000, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: October 11, 2021
• Study Start: January 1, 2021
• Primary Completion: February 3, 2023
• Study Completion: February 3, 2023
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

FR (1)