Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale

Pulmonary Embolism Clinical Trial

— EPIC-FOP  

Official title:

Is There a Link Between Venous Thromboembolism and Stroke in Patient With Patent Foramen Ovale ? Research for Stroke in Hospitalized Patients With Pulmonary Embolism.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216423
• Other study ID #: EPIC-FOP
• Status: Completed
• Phase: N/A
• First received: September 29, 2010
• Last updated: January 11, 2017
• Start date: November 2009
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: January 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Embolism
• Foramen Ovale, Patent
• Patent Foramen Ovale
• Pulmonary Embolism
• Recent Stroke
• Stroke

Locations

Country	Name	City	State
France	Army Hospital	Brest
France	Brest University Hospital	Brest
France	CHU Dijon de Bocage	Dijon
France	Centre Hospitalier de Cornouaille	Quimper

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of recent ischemic stroke in patients hospitalized for a recent pulmonary embolism with comparison in two groups with and without PFO		7 days	Yes