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 January 2015 by University Hospital, Brest
Sponsor:
University Hospital, Brest
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01894204
First received: June 28, 2013
Last updated: January 26, 2015
Last verified: January 2015
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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
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 | Recruiting |
| Lannion, France, 22300 | |
| Contact: Karine PROVOST, MD | |
| Principal Investigator: Karine PROVOST, MD | |
| 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 | 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
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: | January 26, 2015 |
| 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 March 02, 2015