Chronic EmboilismPACTENCT05073666
Prevalence and Risk Factors of Chronic Thrombo-embolic Disease After a Pulmonary Embolism Event
An observational study of Chronic Emboilism, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Emboilism
- How many people
- 123 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 3 Feb 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all PE hospitalized for a pulmonary embolism
Who may be able to join
- 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
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- NO INTERVENTION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO INTERVENTIONOther
NO INTERVENTION
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: NO INTERVENTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 to 6 months after pulmonary embolism
Secondary outcomes (13)
Associated risk factors for CTED occurrence
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
Measured: 3 to 6 months after pulmonary embolism
Associated risk factors for CTED occurrence BMI
The initial risk factors are the classic cardiologic data: BMI (kg / m²)
Measured: 3 to 6 months after pulmonary embolism
Associated risk factors for CTED occurrence D-dimer level
The initial risk factors are the classic cardiologic data: D-dimer level (ng / ml) on arrival
Measured: 3 to 6 months after pulmonary embolism
Associated risk factors for CTED occurrence clinical severity
The initial risk factors are the classic cardiologic data: clinical severity according to ESC criteria
Measured: 3 to 6 months after pulmonary embolism
Associated risk factors for CTED occurrence ultrasound parameters of RV function
The initial risk factors are the classic cardiologic data: clinical severity: ultrasound parameters of RV function
Measured: 3 to 6 months after pulmonary embolism
Associated risk factors for CTED occurrence diameter of the pulmonary artery trunk
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
Measured: 3 to 6 months after pulmonary embolism
Associated risk factors for CTED occurrence need for thrombolytic therapy or infusion of inotropic agent
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
Measured: 3 to 6 months after pulmonary embolism
Associated risk factors for CTED occurrence unprovoked nature of the event
The initial risk factors are the classic cardiologic data: clinical severity: unprovoked nature of the event at the physician's discretion
Measured: 3 to 6 months after pulmonary embolism
Associated risk factors for CTED occurrence time between onset of symptoms and diagnosis
The initial risk factors are the classic cardiologic data: time between onset of symptoms and diagnosis (days)
Measured: 3 to 6 months after pulmonary embolism
Associated risk factors (deep vein thrombosis ) for CTED prevalence
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.
Measured: 3 to 6 months after pulmonary embolism
Associated risk factors (new episode of PE or DVT ) for CTED occurrence
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.
Measured: 3 to 6 months after pulmonary embolism
Associated risk factors (clinical presumption of CTED ) for CTED occurrence
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.
Measured: 3 to 6 months after pulmonary embolism
quality of life score
Assessment of quality of life using the PembQOL score
Measured: 3 to 6 months after pulmonary embolism
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start1 Jan 2021
- Primary completion3 Feb 2023
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic EmboilismStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073666
- Sponsor's protocol ID
- 21Cardio02
- Acronym
- PACTE
- Status last verified
- Mar 2025
- First submitted
- 8 Sep 2021
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors of Chronic Thrombo-embolic Disease After a Pulmonary Embolism Event The PACTE Registry
- ClinicalTrials.gov ID
- NCT05073666
- Acronym / sponsor ID
- PACTE / 21Cardio02
- Conditions
- Chronic Emboilism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pulmonary embolism | – | Other: NO INTERVENTIONPatients 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all PE hospitalized for a pulmonary embolism
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NO INTERVENTIONNO INTERVENTION | Other | pulmonary embolism |
Primary outcome
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).
13 secondary outcomes
Associated risk factors for CTED occurrence
Time frame: 3 to 6 months after pulmonary embolism
Associated risk factors for CTED occurrence BMI
Time frame: 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
Associated risk factors for CTED occurrence clinical severity
Time frame: 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
Associated risk factors for CTED occurrence diameter of the pulmonary artery trunk
Time frame: 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
Associated risk factors for CTED occurrence unprovoked nature of the event
Time frame: 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
Associated risk factors (deep vein thrombosis ) for CTED prevalence
Time frame: 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
Associated risk factors (clinical presumption of CTED ) for CTED occurrence
Time frame: 3 to 6 months after pulmonary embolism
quality of life score
Time frame: 3 to 6 months after pulmonary embolism
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Emboilism, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic thrombo-embolic disease (CTED) prevalence (time frame: 3 to 6 months after pulmonary embolism). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.