Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale

Completed

• Conditions: Pulmonary Embolism; Recent Stroke; Patent Foramen Ovale

• Registration Number: NCT01216423
• Lead Sponsor: University Hospital, Brest

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.

Detailed Description

Inclusion criteria :

* age \> 18 years old

* confirmed pulmonary embolism

* informed consent

* social ensured

Exclusion criteria :

* pregnancy

* age \< 18 years old

* protected major person (in sense of public health)

* consent refused

* MRI contraindications

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-09-29
• Study First Submitted QC: 2010-10-06
• Study First Posted: 2010-10-07
• Primary Completion: 2015-12
• Status Verified: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 374

Inclusion Criteria

• age > 18 years old
• confirmed pulmonary embolism
• informed consent
• social ensured

Exclusion Criteria

• pregnancy
• age < 18 years old
• protected major person (in sense of public health)
• consent refused
• MRI contraindications

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of recent ischemic stroke in patients hospitalized for a recent pulmonary embolism with comparison in two groups with and without PFO	7 days

Trial Locations

Locations (4)

Brest University Hospital; 🇫🇷 Brest, France

Army Hospital; 🇫🇷 Brest, France

CHU Dijon de Bocage; 🇫🇷 Dijon, France

Centre Hospitalier de Cornouaille; 🇫🇷 Quimper, France