Prevalence of Chronic Thromboembolic Pulmonary Hypertension After Acute Pulmonary Embolism : (Preva-CTEPH) (Preva-CTEPH)
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|ClinicalTrials.gov Identifier: NCT03719027|
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : October 8, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Pulmonary Embolism||Diagnostic Test: Study population||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2200 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Retrospective and prospective cohort study|
|Masking:||None (Open Label)|
|Official Title:||Prevalence of Chronic Thromboembolic Pulmonary Hypertension After Acute Pulmonary Embolism. History of the Diagnosis. (Preva-CTEPH) Study|
|Actual Study Start Date :||October 30, 2018|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: Study population
Patients followed-up after the diagnosis of pulmonary embolism (PE) Patients who survived after a PE and who consent to participate to the prospective interventional phase of the PREVA-CTEPH study have dyspnea assessment, EKG, and echocardiography to investigate the diagnosis of CTEPH
Diagnostic Test: Study population
Dyspnea assessment (NYHA functional class) EKG Echocardiography
- Cumulated incidence of CTEPH [ Time Frame: 30-day +/- 15 days after inclusion visit ]Cumulated incidence rate of CTEPH after pulmonary embolism
- Cumulated incidence of CTEPH in patients without previous signs of CTEPH at the time of index PE diagnosis [ Time Frame: 30-day +/- 15 days after inclusion visit ]Cumulated 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 diagnosis [ Time Frame: 30-day +/- 15 days after inclusion visit ]Cumulated incidence rate of CTEPH in patients with previous signs of CTEPH at the time of index PE diagnosis
- Risk factors of CTEPH [ Time Frame: 30-day +/- 15 days after inclusion visit ]Hazard ratio of risk factors independently and significantly associated with the diagnosis of CTEPH after pulmonary embolism
- Complications associated with right heart catheterization [ Time Frame: 30-day +/- 15 days after inclusion visit ]Complication rate of right heart catheterization
- Complications associated with pulmonary angiography [ Time Frame: 30-day +/- 15 days after inclusion visit ]Complication rate of pulmonary angiography
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719027
|Contact: Olivier SANCHEZ, MD, PhDemail@example.com|
|CHU Jean Minjoz||Recruiting|
|Contact: Nicolas MENEVEAU, MD,PhD|
|La Cavale Blanche||Recruiting|
|Contact: Francis Couturaud, MD,PhD|
|Hôpital européen Georges-Pompidou||Recruiting|
|Paris, France, 75015|
|Contact: Olivier Sanchez, MD,PhD +33156093487 firstname.lastname@example.org|
|Contact: Laurent BERTOLETTI, MD,PhD|
|Principal Investigator:||Olivier SANCHEZ, MD, PhD||Université Paris Descartes|