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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University Hospital, Brest
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01894204
First received: June 28, 2013
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

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 Intervention
HTPPE
Idiopathic Pulmonary Embolism
Other: HTPPE

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 "

Resource links provided by NLM:


Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • Frequency of a HTPPE [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mortality and cause [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 374
Study Start Date: June 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Active, not recruiting
Lannion, France, 22300
CHU Hôtel Dieu Active, not recruiting
Nantes, France, 44093
Hôpital Kremlin-Bicêtre Active, not recruiting
Paris, France, 94275
Hôpital Hôtel Dieu Active, not recruiting
Paris, France, 75004
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         
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 Active, not recruiting
Saint-Brieuc, France, 22027
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

No publications provided

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01894204     History of Changes
Other Study ID Numbers: RB 12.161 - PADIS HTP
Study First Received: June 28, 2013
Last Updated: October 14, 2014
Health Authority: ANSM : Agence Nationale de Sécurité des Médicaments et des produits de santé

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

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

ClinicalTrials.gov processed this record on October 20, 2014