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
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Sponsor:
University Hospital, Brest
Information provided by (Responsible Party):
University Hospital, Brest
Tracking Information | ||||
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First Submitted Date ICMJE | June 28, 2013 | |||
First Posted Date ICMJE | July 10, 2013 | |||
Last Update Posted Date | July 20, 2018 | |||
Actual Study Start Date ICMJE | June 27, 2013 | |||
Actual Primary Completion Date | May 29, 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Frequency of a HTPPE [ Time Frame: 24 months ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Mortality and cause [ Time Frame: 24 months ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Determine the Frequency of a HTPPE in 5 Years (± on 1 Year) After a First Episode of Idiopathic Pulmonary Embolism. | |||
Official Title ICMJE | 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 " | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE | 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.
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Study Arms ICMJE | 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.
Intervention: Other: HTPPE
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
235 | |||
Original Estimated Enrollment ICMJE |
374 | |||
Actual Study Completion Date ICMJE | May 29, 2018 | |||
Actual Primary Completion Date | May 29, 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01894204 | |||
Other Study ID Numbers ICMJE | RB 12.161 - PADIS HTP | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | University Hospital, Brest | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | University Hospital, Brest | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | University Hospital, Brest | |||
Verification Date | May 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |