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

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: Recruiting
• Conditions: Chronic Emboilism
• Intervention / Treatment: Other: NO INTERVENTION

• Study Type: Observational
• Enrollment (Anticipated): 540

Contacts and Locations

• Study Contact: Name: emile ferrari; Phone Number: 33492037735; Email: ferrari.e@chu-nice.fr

Study Locations

• France
  • Nice, France, 06000
    • Recruiting
    • Nice University Hospital
    • Contact: emile ferrari; Phone Number: 33492037735; Email: ferrari.e@chu-nice.fr
    • Principal Investigator: Emile Ferrari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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	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	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	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	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	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	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)	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.	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.	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.	3 to 6 months after pulmonary embolism
quality of life score	Assessment of quality of life using the PembQOL score	3 to 6 months after pulmonary embolism

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 30, 2021
• First Posted (Actual): October 11, 2021

Study Record Updates

• Last Update Posted (Actual): October 11, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thromboembolism; Pulmonary Embolism
• Other Study ID 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