NCT00831259

Brief Summary

Pulmonary embolism is associated with a small but definite risk of paradoxical embolism in patients with a patent foramen ovale (PFO). While neurologic complications are unfrequent the incidence of clinically silent brain infarction is unknown. We will assess the rate of clinically apparent and silent cerebral embolism in patients with a pulmonary embolism (PE) in relation to the presence or not of a PFO.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

May 20, 2011

Status Verified

May 1, 2011

Enrollment Period

1.5 years

First QC Date

January 27, 2009

Last Update Submit

May 19, 2011

Conditions

Silent StrokePulmonary EmbolismPatent Foramen Ovale

Keywords

strokePFOembolism

Outcome Measures

Primary Outcomes (1)

  • Incidence of cerebral infarcts as detected by Diffusion-weighted MRI

    during hospitalization

Study Arms (2)

1

Incidence of silent stroke in patients with PFO

2

Incidence of silent stroke in patients without PFO

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive series of patients with a pulmonary embolism

You may qualify if:

  • Pulmonary embolism, informed consent signed, no-contraindication to MRI

You may not qualify if:

  • contra-indication to MRI, informed consent not obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USIC CHU de Caen

Caen, 14033, France

Location

MeSH Terms

Conditions

Pulmonary EmbolismForamen Ovale, PatentStrokeEmbolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesHeart Septal Defects, AtrialHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 27, 2009

First Posted

January 28, 2009

Study Start

October 1, 2007

Primary Completion

April 1, 2009

Study Completion

May 1, 2009

Last Updated

May 20, 2011

Record last verified: 2011-05

Locations

FR(1)