Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale

NCT ID: NCT01216423

Last Updated: 2017-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

374 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2017-01-31

Brief Summary

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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

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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

Conditions

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Recent Stroke Pulmonary Embolism Patent Foramen Ovale

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Incidence of recent stroke in patients with PFO

No interventions assigned to this group

Incidence of recent stroke in patients without PFO

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuelle LE MOIGNE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Brest

Locations

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Army Hospital

Brest, France, France

Site Status

CHU Dijon de Bocage

Dijon, France, France

Site Status

Centre Hospitalier de Cornouaille

Quimper, France, France

Site Status

Brest University Hospital

Brest, , France

Site Status

Countries

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France

References

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Le Moigne E, Timsit S, Ben Salem D, Didier R, Jobic Y, Paleiron N, Le Mao R, Joseph T, Hoffmann C, Dion A, Rousset J, Le Gal G, Lacut K, Leroyer C, Mottier D, Couturaud F. Patent Foramen Ovale and Ischemic Stroke in Patients With Pulmonary Embolism: A Prospective Cohort Study. Ann Intern Med. 2019 Jun 4;170(11):756-763. doi: 10.7326/M18-3485. Epub 2019 May 7.

Reference Type DERIVED
PMID: 31060047 (View on PubMed)

Other Identifiers

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EPIC-FOP

Identifier Type: -

Identifier Source: org_study_id

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