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

• ClinicalTrials.gov Identifier: NCT01894204
• Recruitment Status: Terminated
• First Posted: July 10, 2013
• Last Update Posted: July 20, 2018
• Sponsor: University Hospital, Brest
• Information provided by (Responsible Party): University Hospital, Brest

Tracking Information

• First Submitted Date: June 28, 2013
• First Posted Date: July 10, 2013
• Last Update Posted Date: July 20, 2018
• Actual Study Start Date: June 27, 2013
• Actual Primary Completion Date: May 29, 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 3, 2013): Frequency of a HTPPE [ Time Frame: 24 months ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01894204 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: July 3, 2013): Mortality and cause [ Time Frame: 24 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Determine the Frequency of a HTPPE in 5 Years (± on 1 Year) After a First Episode of Idiopathic Pulmonary Embolism.
• 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 "
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• HTPPE
• Idiopathic Pulmonary Embolism

Intervention

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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: July 19, 2018): 235
• Original Estimated Enrollment (submitted: July 3, 2013): 374
• Actual Study Completion Date: May 29, 2018
• Actual Primary Completion Date: May 29, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01894204
• Other Study ID Numbers: 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: University Hospital, Brest
• Collaborators: Not Provided

Investigators

• Principal Investigator: Francis COUTURAUD, PU-PH; CHRU de Brest

• PRS Account: University Hospital, Brest
• Verification Date: May 2018