NCT04987008

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 ?

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

August 3, 2021

Status Verified

April 1, 2021

Enrollment Period

4 months

First QC Date

July 27, 2021

Last Update Submit

August 2, 2021

Conditions

Foramen Ovale, Patent

Keywords

foramen ovale, patentstrokepulmonary embolism

Outcome Measures

Primary Outcomes (1)

  • stroke

    documented stroke

    pulmonary embolism (2009 to 2015) to 2021

Secondary Outcomes (4)

  • TIA or stroke

    pulmonary embolism (2009 to 2015) to 2021

  • death

    pulmonary embolism (2009 to 2015) to 2021

  • bleeding

    pulmonary embolism (2009 to 2015) to 2021

  • VTE

    pulmonary embolism (2009 to 2015) to 2021

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • patients included in EPIC-FOP study

You may not qualify if:

  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

HIA

Brest, 29600, France

RECRUITING

CHRU de Brest

Brest, 29609, France

RECRUITING

CHIC de Quimper

Quimper, 29000, France

RECRUITING

MeSH Terms

Conditions

Foramen Ovale, PatentStrokePulmonary Embolism

Condition Hierarchy (Ancestors)

Heart Septal Defects, AtrialHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and Thrombosis

Central Study Contacts

Emmanuelle LE MOIGNE

CONTACT

0298347344emmanuelle.lemoigne@chu-brest.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2021

First Posted

August 3, 2021

Study Start

May 18, 2021

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

August 3, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication.

Shared Documents
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.

Locations

FR(3)