Risk of Ischaemic Stroke After Pulmonary Embolism in Pati... | NCT04987008

Studies
Risk of Ischaemic Stroke After Pulmonary Embolism in Patients With and Without Patent Foramen Ovale

NCT04987008

Sponsor

University Hospital, Brest

Status

Unknown status

Last Update Posted

Aug 3, 2021Actual

Enrollment

53Estimated

Phase

Not provided

Conditions

Foramen Ovale, Patent

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

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 18, 2021Actual

Primary Completion Date

Aug 31, 2021Estimated

Completion Date

Aug 31, 2021Estimated

First Submitted Date

Jul 27, 2021

First Submission Date that Met QC Criteria

Aug 2, 2021

First Posted Date

Aug 3, 2021Actual

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

Aug 2, 2021

Last Update Posted Date

Aug 3, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

stroke's risk is increased in patients with pulmonary embolism and PFO compared to patients without PFO. Does this increased risk persist years after pulmonary embolism ?

Detailed Description

324 patients included in EPIC-FOP study (2009 to 2015) were followed annually to collect data about the recurrence of VTE, cardiovascular events and treatments.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

53Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
stroke	documented stroke	pulmonary embolism (2009 to 2015) to 2021

Secondary Outcomes

Measure	Description	Time Frame
TIA or stroke	documented TIA or stroke	pulmonary embolism (2009 to 2015) to 2021
death	all deaths and cardiovascular deaths	pulmonary embolism (2009 to 2015) to 2021

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients included in EPIC-FOP study

Exclusion Criteria:

refusal to participate

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

53 of the 324 EPIC-FOP patients not followed in previous PE cohort

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Emmanuelle LE MOIGNE	Contact	0298347344		emmanuelle.lemoigne@chu-brest.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HIA	Recruiting	Brest		29600	France

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All collected data that underlie results in a publication.

Types

Study Protocol

Time Frame

Data will be available beginning three years and ending five years following the final study report completion.

Access Criteria

Data access request will be reviewed by the internal committee of Brest University Hospital. Requestor will be required to sign and complete a data access agreement.

URL

Not provided

Condition Browse Module

MeSH Terms

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

Ancestor Terms

ID	Term
D006344	Heart Septal Defects, Atrial
D006343	Heart Septal Defects
D006330	Heart Defects, Congenital
D018376	Cardiovascular Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided