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Prevalence of Chronic Thromboembolic Pulmonary Hypertension After Acute Pulmonary Embolism : (Preva-CTEPH)

Prevalence of Chronic Thromboembolic Pulmonary Hypertension After Acute Pulmonary Embolism. History of the Diagnosis. (Preva-CTEPH) Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03719027
Acronym
Preva-CTEPH
Enrollment
2003
Registered
2018-10-25
Start date
2018-10-30
Completion date
2022-06-29
Last updated
2024-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Pulmonary Embolism

Keywords

Prevalence and incidence of CTEPH after pulmonary embolism, history of diagnosis

Brief summary

The prevalence of chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary embolism (PE) varies widely (0.4% to 8.8%) in the literature. This large variation could be due to the inclusion of patients with pre-existing CTEPH revealed on the occasion of a recurrence of PE. However, the absence of hemodynamic data when diagnosing PE does not allow to distinguish these patients. A prospective multicentric study involving 146 patients showed that the majority of patients with CTEPH during follow-up had a pulmonary hypertension unknown at the time of PE diagnosis. It is necessary to confirm these results in a broader study. The aim of this study is to evaluate the cumulative incidence of CTEPH after a PE.

Detailed description

The patients selected in this study are patients with an objectively confirmed PE and previously included since at least 12 months in one of the studies of the INNOVTE network. Patients who are alive at the time of the selection for the PREVA-CTEPH study are contacted by phone or by mail for inclusion in the prospective interventional part of the PREVA-CTEPH study. Patients who consent to participate to this prospective interventional phase of the PREVA-CTEPH study have dyspnea assessment, EKG, and echocardiography to investigate the diagnosis of CTEPH. Patients with dyspnea (NYHA \>1) and/or a high or intermediate echocardiographic probability of pulmonary hypertension (ESC criteria) have a V/Q lung scan, a right heart catheterization and a pulmonary angiography to objectively confirm the diagnosis of CTEPH according to the current ESC guidelines. Retrospective phase: All clinical (dyspnea, signs of right ventricular insufficiency...), echocardiographic and imaging (pulmonary angiography, V/Q lung scan) relevant data after the diagnosis of index PE are retrieved from the clinical chart of each patients alive at the time of the selection for the PREVA-CTEPH study and/or with a diagnosis of CTEPH confirmed after the diagnosis of index PE and/or if the patient don't consent to participate to the prospective interventional phase. For patients died between the inclusion in one of the studies of the INNOVTE network and the time of the selection for the PREVA-CTEPH study, the date and the cause of death are recorded. The same data of the retrospective phase are retrieved. All cases of CTEPH are adjudicated by an independent committee. In this case, initial Imaging data (CT pulmonary angiography and echocardiography) performed at the time of index PE diagnosis are retrieved for searching previous sign of CTEPH.

Interventions

DIAGNOSTIC_TESTStudy population

Dyspnea assessment (NYHA functional class) EKG Echocardiography

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Retrospective and prospective cohort study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients older than 18 years * Pulmonary embolism objectively confirmed * Treated during at least 3 months with curative anticoagulant * Previously included since at least 1 year in one of the studies of the INNOVTE network * affiliated to the national social security * after written informed consent

Exclusion criteria

* Patients with an objectively confirmed CTEPH before the diagnosis of index PE * Follow-up impossible

Design outcomes

Primary

MeasureTime frameDescription
Cumulated incidence of CTEPH30-day +/- 15 days after inclusion visitCumulated incidence rate of CTEPH after pulmonary embolism

Secondary

MeasureTime frameDescription
Cumulated incidence of CTEPH in patients without previous signs of CTEPH at the time of index PE diagnosis30-day +/- 15 days after inclusion visitCumulated incidence rate of CTEPH in patients without previous signs of CTEPH at the time of index PE diagnosis
Cumulated incidence of CTEPH in patients with previous signs of CTEPH at the time of index PE diagnosis30-day +/- 15 days after inclusion visitCumulated incidence rate of CTEPH in patients with previous signs of CTEPH at the time of index PE diagnosis
Risk factors of CTEPH30-day +/- 15 days after inclusion visitHazard ratio of risk factors independently and significantly associated with the diagnosis of CTEPH after pulmonary embolism
Complications associated with right heart catheterization30-day +/- 15 days after inclusion visitComplication rate of right heart catheterization
Complications associated with pulmonary angiography30-day +/- 15 days after inclusion visitComplication rate of pulmonary angiography

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026