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

Tracking Information
First Submitted Date ICMJE	June 28, 2013
First Posted Date ICMJE	July 10, 2013
Last Update Posted Date	April 4, 2018
Actual Study Start Date ICMJE	June 27, 2013
Estimated Primary Completion Date	April 27, 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 3, 2013)	Frequency of a HTPPE [ Time Frame: 24 months ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01894204 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 3, 2013)	Mortality and cause [ Time Frame: 24 months ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
Condition ICMJE	HTPPE; Idiopathic Pulmonary Embolism
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.
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: July 3, 2013)	374
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	December 27, 2018
Estimated Primary Completion Date	April 27, 2018 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Francis COUTURAUD, PU-PH francis.couturaud@chu-brest.fr
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	Not Provided
Responsible Party	University Hospital, Brest
Study Sponsor ICMJE	University Hospital, Brest
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Francis COUTURAUD, PU-PH CHRU de Brest
PRS Account	University Hospital, Brest
Verification Date	April 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP