NCT03719027

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,003

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

October 30, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2022

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

3.7 years

First QC Date

October 23, 2018

Last Update Submit

May 2, 2024

Conditions

Chronic Thromboembolic Pulmonary Hypertension (CTEPH)Pulmonary Embolism

Keywords

Prevalence and incidence of CTEPH after pulmonary embolismhistory of diagnosis

Outcome Measures

Primary Outcomes (1)

  • Cumulated incidence of CTEPH

    Cumulated incidence rate of CTEPH after pulmonary embolism

    30-day +/- 15 days after inclusion visit

Secondary Outcomes (5)

  • Cumulated incidence of CTEPH in patients without previous signs of CTEPH at the time of index PE diagnosis

    30-day +/- 15 days after inclusion visit

  • Cumulated incidence of CTEPH in patients with previous signs of CTEPH at the time of index PE diagnosis

    30-day +/- 15 days after inclusion visit

  • Risk factors of CTEPH

    30-day +/- 15 days after inclusion visit

  • Complications associated with right heart catheterization

    30-day +/- 15 days after inclusion visit

  • Complications associated with pulmonary angiography

    30-day +/- 15 days after inclusion visit

Study Arms (1)

Study population

EXPERIMENTAL

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

Interventions

Study populationDIAGNOSTIC_TEST

Dyspnea assessment (NYHA functional class) EKG Echocardiography

Study population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU Jean Minjoz

Besançon, France

Location

La Cavale Blanche

Brest, France

Location

Hôpital européen Georges-Pompidou

Paris, 75015, France

Location

Hôpital Nord

Saint-Etienne, France

Location

Related Publications (2)

  • 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.

    PMID: 24898545RESULT

  • 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.

    PMID: 28232411RESULT

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Olivier SANCHEZ, MD, PhD

    Université Paris Descartes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Retrospective and prospective cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2018

First Posted

October 25, 2018

Study Start

October 30, 2018

Primary Completion

June 29, 2022

Study Completion

June 29, 2022

Last Updated

May 3, 2024

Record last verified: 2024-05

Locations

FR(4)