Determine the Frequency of a HTPPE in 5 Years (± on 1 Year) After a First Episode of Idiopathic Pulmonary Embolism.

NCT ID: NCT01894204

Last Updated: 2018-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-27

Study Completion Date

2018-05-29

Brief Summary

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Forward-looking troop established(constituted) by the patients having been included in the study " PADIS EP ", PHRC on 2006 and 2009, randomized checked(controlled), double-blind, comparing an anticoagulating treatment(processing) extended by coumadine versus placebo during 18 months at patients having had a first episode of EP idiopathique treated(handled) initially 6 months by anti-vitamin K.

Detailed Description

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Conditions

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HTPPE Idiopathic Pulmonary Embolism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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HTPPE

No drug and no placebo were used in this study. For all the patients who participated at the study PADIS-EP, somme exams must be performed.

Group Type OTHER

HTPPE

Intervention Type OTHER

No drug and no placebo were used in this study. Some exams must be performed (DLCO - evaluation of the dyspnoea and pulmonary scintigraphy), and in function of the result of the pulmonary scintigraphy, the medical care of the patient will be different : negative pulmonary scintigraphy, stop of the explorations and taken care usual of the patients; positive pulmonary scintigraphy,realisation of a cardiac echography to estimate the presence or not of a not very probable, possible or likely HTP. The indication of the right cardiac catheterization is then put on the combination of the results of the cardiac echography and the evaluation of the dyspnoea.

Interventions

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HTPPE

No drug and no placebo were used in this study. Some exams must be performed (DLCO - evaluation of the dyspnoea and pulmonary scintigraphy), and in function of the result of the pulmonary scintigraphy, the medical care of the patient will be different : negative pulmonary scintigraphy, stop of the explorations and taken care usual of the patients; positive pulmonary scintigraphy,realisation of a cardiac echography to estimate the presence or not of a not very probable, possible or likely HTP. The indication of the right cardiac catheterization is then put on the combination of the results of the cardiac echography and the evaluation of the dyspnoea.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients having ended the study PADIS EP after the visit of the end of study and having signed the consent HTP.

Exclusion Criteria

* Refusal to grant in writing to participate in the study PADIS HTP
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francis COUTURAUD, PU-PH

Role: PRINCIPAL_INVESTIGATOR

CHRU de Brest

Locations

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CHRU de Brest

Brest, , France

Site Status

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

CH de Lannion

Lannion, , France

Site Status

Hôpital Européen Georges Pompidou

Paris, , France

Site Status

CHU Pontchaillou - Hôpital Sud

Rennes, , France

Site Status

Hôpital Yves Le Foll

Saint-Brieuc, , France

Site Status

Hôpital de Bellevue - CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Hôpital Rangueuil

Toulouse, , France

Site Status

Countries

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France

References

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Fauche A, Presles E, Sanchez O, Jais X, Le Mao R, Robin P, Pernod G, Bertoletti L, Jego P, Parent F, Lemarie CA, Leven F, Le Roux PY, Salaun PY, Nonent M, Girard P, Lacut K, Savale L, Melac S, Guegan M, Mismetti P, Laporte S, Leroyer C, Montani D, Couturaud F, Tromeur C; PADIS-PE Investigators. Frequency and predictors for chronic thromboembolic pulmonary hypertension after a first unprovoked pulmonary embolism: Results from PADIS studies. J Thromb Haemost. 2022 Dec;20(12):2850-2861. doi: 10.1111/jth.15866. Epub 2022 Sep 25.

Reference Type DERIVED
PMID: 36017744 (View on PubMed)

Other Identifiers

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RB 12.161 - PADIS HTP

Identifier Type: -

Identifier Source: org_study_id

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