Risk of Ischaemic Stroke After Pulmonary Embolism in Patients With and Without Patent Foramen Ovale

• Conditions: Foramen Ovale, Patent

• Registration Number: NCT04987008
• Lead Sponsor: University Hospital, Brest

Brief Summary

stroke's risk is increased in patients with pulmonary embolism and PFO compared to patients without PFO. Does this increased risk persist years after pulmonary embolism ?

Detailed Description

324 patients included in EPIC-FOP study (2009 to 2015) were followed annually to collect data about the recurrence of VTE, cardiovascular events and treatments.

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-05-18
• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-08-02
• Last Update Submitted: 2021-08-02
• Study First Posted: 2021-08-03
• Last Update Posted: 2021-08-03
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• patients included in EPIC-FOP study

Exclusion Criteria

• refusal to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
stroke	pulmonary embolism (2009 to 2015) to 2021	documented stroke

Secondary Outcome Measures

Name	Time	Method
VTE	pulmonary embolism (2009 to 2015) to 2021	recurrent VTE
TIA or stroke	pulmonary embolism (2009 to 2015) to 2021	documented TIA or stroke
death	pulmonary embolism (2009 to 2015) to 2021	all deaths and cardiovascular deaths
bleeding	pulmonary embolism (2009 to 2015) to 2021	Major and clinically pertinent bleeding (ISTH classification)

Trial Locations

Locations (3)

HIA; 🇫🇷 Brest, France

CHRU de Brest; 🇫🇷 Brest, France

CHIC de Quimper; 🇫🇷 Quimper, France