Prevalence of Chronic Thromboembolic Pulmonary Hypertension After Acute Pulmonary Embolism : (Preva-CTEPH) (Preva-CTEPH)
Primary Purpose
Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Pulmonary Embolism
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Study population
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Thromboembolic Pulmonary Hypertension (CTEPH) focused on measuring Prevalence and incidence of CTEPH after pulmonary embolism, history of diagnosis
Eligibility 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
Sites / Locations
- CHU Jean MinjozRecruiting
- La Cavale BlancheRecruiting
- Hôpital européen Georges-PompidouRecruiting
- Hôpital NordRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study population
Arm Description
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
Outcomes
Primary Outcome Measures
Cumulated incidence of CTEPH
Cumulated incidence rate of CTEPH after pulmonary embolism
Secondary Outcome Measures
Cumulated incidence of CTEPH in patients without previous signs of CTEPH at the time of index PE diagnosis
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
Cumulated incidence rate of CTEPH in patients with previous signs of CTEPH at the time of index PE diagnosis
Risk factors of CTEPH
Hazard ratio of risk factors independently and significantly associated with the diagnosis of CTEPH after pulmonary embolism
Complications associated with right heart catheterization
Complication rate of right heart catheterization
Complications associated with pulmonary angiography
Complication rate of pulmonary angiography
Full Information
NCT ID
NCT03719027
First Posted
October 23, 2018
Last Updated
October 1, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT03719027
Brief Title
Prevalence of Chronic Thromboembolic Pulmonary Hypertension After Acute Pulmonary Embolism : (Preva-CTEPH)
Acronym
Preva-CTEPH
Official Title
Prevalence of Chronic Thromboembolic Pulmonary Hypertension After Acute Pulmonary Embolism. History of the Diagnosis. (Preva-CTEPH) Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Pulmonary Embolism
Keywords
Prevalence and incidence of CTEPH after pulmonary embolism, history of diagnosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Retrospective and prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
2200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study population
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Study population
Intervention Description
Dyspnea assessment (NYHA functional class) EKG Echocardiography
Primary Outcome Measure Information:
Title
Cumulated incidence of CTEPH
Description
Cumulated incidence rate of CTEPH after pulmonary embolism
Time Frame
30-day +/- 15 days after inclusion visit
Secondary Outcome Measure Information:
Title
Cumulated incidence of CTEPH in patients without previous signs of CTEPH at the time of index PE diagnosis
Description
Cumulated incidence rate 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
Title
Cumulated incidence of CTEPH in patients with previous signs of CTEPH at the time of index PE diagnosis
Description
Cumulated incidence rate 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
Title
Risk factors of CTEPH
Description
Hazard ratio of risk factors independently and significantly associated with the diagnosis of CTEPH after pulmonary embolism
Time Frame
30-day +/- 15 days after inclusion visit
Title
Complications associated with right heart catheterization
Description
Complication rate of right heart catheterization
Time Frame
30-day +/- 15 days after inclusion visit
Title
Complications associated with pulmonary angiography
Description
Complication rate of pulmonary angiography
Time Frame
30-day +/- 15 days after inclusion visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier SANCHEZ, MD, PhD
Phone
+33156093487
Email
olivier.sanchez@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier SANCHEZ, MD, PhD
Organizational Affiliation
Université Paris Descartes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Jean Minjoz
City
Besançon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas MENEVEAU, MD,PhD
Facility Name
La Cavale Blanche
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis Couturaud, MD,PhD
Facility Name
Hôpital européen Georges-Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Sanchez, MD,PhD
Phone
+33156093487
Email
olivier.sanchez@aphp.fr
Facility Name
Hôpital Nord
City
Saint-Étienne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent BERTOLETTI, MD,PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Individual patient level meta-analysis for cumulative incidence rate and risk factors of CTEPH after PE
Citations:
PubMed Identifier
24898545
Citation
Guerin L, Couturaud F, Parent F, Revel MP, Gillaizeau F, Planquette B, Pontal D, Guegan M, Simonneau G, Meyer G, Sanchez O. Prevalence of chronic thromboembolic pulmonary hypertension after acute pulmonary embolism. Prevalence of CTEPH after pulmonary embolism. Thromb Haemost. 2014 Sep 2;112(3):598-605. doi: 10.1160/TH13-07-0538. Epub 2014 Jun 5.
Results Reference
result
PubMed Identifier
28232411
Citation
Ende-Verhaar YM, Cannegieter SC, Vonk Noordegraaf A, Delcroix M, Pruszczyk P, Mairuhu AT, Huisman MV, Klok FA. Incidence of chronic thromboembolic pulmonary hypertension after acute pulmonary embolism: a contemporary view of the published literature. Eur Respir J. 2017 Feb 23;49(2):1601792. doi: 10.1183/13993003.01792-2016. Print 2017 Feb.
Results Reference
result
Learn more about this trial
Prevalence of Chronic Thromboembolic Pulmonary Hypertension After Acute Pulmonary Embolism : (Preva-CTEPH)
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