Risk of Ischaemic Stroke After Pulmonary Embolism in Patients With and Without Patent Foramen Ovale (EPIC-FOPCohort)

August 2, 2021 updated by: University Hospital, Brest

Risk of Ischaemic Stroke After Pulmonary Embolism in Patients With and Without Patent Foramen Ovale (29BRC21.0082)

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 ?

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Brest, France, 29609
        • Recruiting
        • CHRU de Brest
        • Contact:
          • Emmanuelle LE MOIGNE
      • Brest, France, 29600
        • Recruiting
        • HIA
        • Contact:
          • Marc Danguy des Déserts
      • Quimper, France, 29000
        • Recruiting
        • CHIC de Quimper
        • Contact:
          • Thierry JOSEPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • patients included in EPIC-FOP study

Exclusion Criteria:

  • refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TIA or stroke
Time Frame: pulmonary embolism (2009 to 2015) to 2021
documented TIA or stroke
pulmonary embolism (2009 to 2015) to 2021
death
Time Frame: pulmonary embolism (2009 to 2015) to 2021
all deaths and cardiovascular deaths
pulmonary embolism (2009 to 2015) to 2021
bleeding
Time Frame: pulmonary embolism (2009 to 2015) to 2021
Major and clinically pertinent bleeding (ISTH classification)
pulmonary embolism (2009 to 2015) to 2021
VTE
Time Frame: pulmonary embolism (2009 to 2015) to 2021
recurrent VTE
pulmonary embolism (2009 to 2015) to 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2021

Primary Completion (Anticipated)

August 31, 2021

Study Completion (Anticipated)

August 31, 2021

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

August 2, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cohorte EPIC-FOP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All collected data that underlie results in a publication.

IPD Sharing Time Frame

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

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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