Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale (EPIC-FOP)
This study is currently recruiting participants.
Verified May 2013 by University Hospital, Brest
Sponsor:
University Hospital, Brest
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01216423
First received: September 29, 2010
Last updated: May 16, 2013
Last verified: May 2013
| Tracking Information | |||||
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| First Received Date ICMJE | September 29, 2010 | ||||
| Last Updated Date | May 16, 2013 | ||||
| Start Date ICMJE | November 2009 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Incidence of recent ischemic stroke in patients hospitalized for a recent pulmonary embolism with comparison in two groups with and without PFO [ Time Frame: 7 days ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01216423 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale | ||||
| Official Title ICMJE | Is There a Link Between Venous Thromboembolism and Stroke in Patient With Patent Foramen Ovale ? Research for Stroke in Hospitalized Patients With Pulmonary Embolism. | ||||
| Brief Summary | The cause of ischemic stroke remains frequently unknown. In patients with patent foramen ovale (PFO), the link between PFO and Stroke is unclear. The investigators hypothesize that the main mechanism is paradoxical embolism and decided to look for clinically apparent and silent cerebral embolism in patients with a recent pulmonary embolism. |
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| Detailed Description | Inclusion criteria :
Exclusion criteria :
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Consecutive series of hospitalized patients with pulmonary embolism |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 297 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01216423 | ||||
| Other Study ID Numbers ICMJE | EPIC-FOP | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | University Hospital, Brest | ||||
| Study Sponsor ICMJE | University Hospital, Brest | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Brest | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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