Risk of Stroke in Pulmonary Embolism With a Patent Forame... | NCT00831259

Studies
Risk of Stroke in Pulmonary Embolism With a Patent Foramen Ovale (PFO)

NCT00831259

Sponsor

University Hospital, Caen

Status

Completed

Last Update Posted

May 20, 2011Estimated

Enrollment

70Estimated

Phase

Not provided

Conditions

Silent Stroke
Pulmonary Embolism
Patent Foramen Ovale

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Apr 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Jan 27, 2009

First Submission Date that Met QC Criteria

Jan 27, 2009

First Posted Date

Jan 28, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2011

Last Update Posted Date

May 20, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Incidence of silent stroke in patients with PFO
2		Incidence of silent stroke in patients without PFO

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of cerebral infarcts as detected by Diffusion-weighted MRI		during hospitalization

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

contra-indication to MRI, informed consent not obtained

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Consecutive series of patients with a pulmonary embolism

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
USIC CHU de Caen		Caen		14033	France

Condition Browse Module

MeSH Terms

ID	Term
D011655	Pulmonary Embolism
D054092	Foramen Ovale, Patent
D020521	Stroke
D004617	Embolism

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D016769	Embolism and Thrombosis
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided