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

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ClinicalTrials.gov Identifier: NCT01894204
Recruitment Status : Recruiting
First Posted : July 10, 2013
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HTPPE Idiopathic Pulmonary Embolism Other: HTPPE Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 374 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Frequency and Risk Factors of the Lung High Blood Pressure Post-embolique in the Fall of a First Episode of Idiopathic Pulmonary Embolism. Study " PADIS HTP "
Actual Study Start Date : June 27, 2013
Estimated Primary Completion Date : April 27, 2018
Estimated Study Completion Date : December 27, 2018

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Arms and Interventions
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Arm Intervention/treatment
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.
 Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of a HTPPE [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Mortality and cause [ Time Frame: 24 months ]

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

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
Contacts and Locations
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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): NCT01894204


Contacts
Contact: Francis COUTURAUD, PU-PH francis.couturaud@chu-brest.fr

Locations
France
CHRU de Brest Recruiting
Brest, France, 29609
Contact: Francis COUTURAUD, PU-PH         
Principal Investigator: Francis COUTURAUD, PU-PH         
Sub-Investigator: Luc De Saint-Martin, MD         
Sub-Investigator: Karine LACUT, PU-PH         
Sub-Investigator: Christophe LEROYER, MD         
Sub-Investigator: Dominique MOTTIER, PU-PH         
Sub-Investigator: Elisabeth PASQUIER, MD         
Sub-Investigator: Christophe GUT-GOBERT, MD         
Sub-Investigator: Emmanuelle LEMOIGNE, MD         
Sub-Investigator: Pierre-Yves SALAUN, PU-PH         
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Jeannot SCHMIDT, MD         
Principal Investigator: Jeannot SCHMIDT, MD         
Hôpital Nord Active, not recruiting
Grenoble, France, 38043
CH de Lannion Recruiting
Lannion, France, 22300
Contact: Karine PROVOST, MD         
Principal Investigator: Karine PROVOST, MD         
CHU Hôtel Dieu Active, not recruiting
Nantes, France, 44093
Hôpital Européen Georges Pompidou Recruiting
Paris cedex 15, France, 75908
Contact: Olivier SANCHEZ, MD         
Principal Investigator: Olivier SANCHEZ, MD         
Sub-Investigator: Guy MEYER, PU-PH         
Hôpital Hôtel Dieu Active, not recruiting
Paris, France, 75004
Hôpital Kremlin-Bicêtre Active, not recruiting
Paris, France, 94275
Centre Hospitalier de Cornouaille Not yet recruiting
Quimper, France, 29107
Contact: Pierre Jézéquel, MD         
Principal Investigator: Pierre JEZEQUEL, MD         
CHU Pontchaillou - Hôpital Sud Recruiting
Rennes, France, 35056
Contact: Patrick JEGO, PU-PH         
Principal Investigator: Patrick JEGO, PU-PH         
Hôpital Yves Le Foll Recruiting
Saint-Brieuc, France, 22027
Contact: Elisabeth DUHAMEL, MD         
Principal Investigator: Elisabeth DUHAMEL, MD         
Hôpital de Bellevue - CHU de Saint-Etienne Recruiting
Saint-Etienne, France, 45055
Contact: Patrick MISMETTI, PU-PH         
Principal Investigator: Patrick MISMETTI, PU-PH         
Sub-Investigator: Hervé DECOUSUS, PU-PH         
Hôpital Rangueuil Active, not recruiting
Toulouse, France, 31059
CHU Trousseau Not yet recruiting
Tours, France, 37044
Contact: Yves Gruel, PU-PH         
Principal Investigator: Yves GRUEL, PU-PH         
Sub-Investigator: Bénédicte DELAHOUSSE, MD         
Sub-Investigator: Sandra REGINA, MD         
Sponsors and Collaborators
University Hospital, Brest
Investigators
Principal Investigator: Francis COUTURAUD, PU-PH CHRU de Brest
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01894204     History of Changes
Other Study ID Numbers: RB 12.161 - PADIS HTP
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

Keywords provided by University Hospital, Brest:
HTTPE
Idiopathic Pulmonary embolism

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases