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

March 5, 2025 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
123

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Nice, France, 06000
        • Nice University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

all PE hospitalized for a pulmonary embolism

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
NO INTERVENTION

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
3 to 6 months after pulmonary embolism

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
3 to 6 months after pulmonary embolism
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 to 6 months after pulmonary embolism
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
3 to 6 months after pulmonary embolism
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
3 to 6 months after pulmonary embolism
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
3 to 6 months after pulmonary embolism
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
3 to 6 months after pulmonary embolism
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
3 to 6 months after pulmonary embolism
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
3 to 6 months after pulmonary embolism
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)
3 to 6 months after pulmonary embolism
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.
3 to 6 months after pulmonary embolism
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.
3 to 6 months after pulmonary embolism
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.
3 to 6 months after pulmonary embolism
quality of life score
Time Frame: 3 to 6 months after pulmonary embolism
Assessment of quality of life using the PembQOL score
3 to 6 months after pulmonary embolism

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 3, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21Cardio02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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