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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 : Terminated (The maximum of inclusions was reached)
First Posted : July 10, 2013
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Study Description
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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)
Actual Enrollment : 235 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
Actual Primary Completion Date : May 29, 2018
Actual Study Completion Date : May 29, 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, Older Adult)
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


Locations
France
CHRU de Brest
Brest, France, 29609
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
CH de Lannion
Lannion, France, 22300
Hôpital Européen Georges Pompidou
Paris cedex 15, France, 75908
CHU Pontchaillou - Hôpital Sud
Rennes, France, 35056
Hôpital Yves Le Foll
Saint-Brieuc, France, 22027
Hôpital de Bellevue - CHU de Saint-Etienne
Saint-Etienne, France, 45055
Hôpital Rangueuil
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Brest
Investigators
Principal Investigator: Francis COUTURAUD, PU-PH CHRU de Brest
More Information
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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: July 20, 2018
Last Verified: May 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