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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
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Pulmonary Embolism Diagnostic Test: Study population Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Retrospective and prospective cohort study
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Cumulated incidence of CTEPH [ Time Frame: 30-day +/- 15 days after inclusion visit ]
    Cumulated incidence rate of CTEPH after pulmonary embolism


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Complications associated with right heart catheterization [ Time Frame: 30-day +/- 15 days after inclusion visit ]
    Complication rate of right heart catheterization

  5. Complications associated with pulmonary angiography [ Time Frame: 30-day +/- 15 days after inclusion visit ]
    Complication rate of pulmonary angiography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Olivier SANCHEZ, MD, PhD +33156093487 olivier.sanchez@aphp.fr

Locations
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France
CHU Jean Minjoz Recruiting
Besançon, France
Contact: Nicolas MENEVEAU, MD,PhD         
La Cavale Blanche Recruiting
Brest, France
Contact: Francis Couturaud, MD,PhD         
Hôpital européen Georges-Pompidou Recruiting
Paris, France, 75015
Contact: Olivier Sanchez, MD,PhD    +33156093487    olivier.sanchez@aphp.fr   
Hôpital Nord Recruiting
Saint-Étienne, France
Contact: Laurent BERTOLETTI, MD,PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Olivier SANCHEZ, MD, PhD Université Paris Descartes
Publications of Results:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03719027    
Other Study ID Numbers: K161203J
2017-A02047-46 ( Other Identifier: ANSM )
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Individual patient level meta-analysis for cumulative incidence rate and risk factors of CTEPH after PE

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Prevalence and incidence of CTEPH after pulmonary embolism
history of diagnosis
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Pulmonary Embolism
Hypertension
Embolism
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Embolism and Thrombosis