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NCT04987008 Clinical Trial

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

Foramen Ovale, Patent Clinical Trial

— EPIC-FOPCohort  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04987008
Other study ID # Cohorte EPIC-FOP
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 18, 2021
Est. completion date August 31, 2021

Study information
Verified date April 2021
Source University Hospital, Brest
Contact Emmanuelle LE MOIGNE
Phone 0298347344
Email emmanuelle.lemoigne@chu-brest.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 ?

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 53
Est. completion date August 31, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients included in EPIC-FOP study Exclusion Criteria: - refusal to participate

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHRU de Brest Brest
France HIA Brest
France CHIC de Quimper Quimper

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary stroke documented stroke pulmonary embolism (2009 to 2015) to 2021
Secondary TIA or stroke documented TIA or stroke pulmonary embolism (2009 to 2015) to 2021
Secondary death all deaths and cardiovascular deaths pulmonary embolism (2009 to 2015) to 2021
Secondary bleeding Major and clinically pertinent bleeding (ISTH classification) pulmonary embolism (2009 to 2015) to 2021
Secondary VTE recurrent VTE pulmonary embolism (2009 to 2015) to 2021
See also
  Status Clinical Trial Phase
Completed NCT00196040 - The Paradigm II Trial: PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness N/A
Recruiting NCT01934725 - Searching for Explanations for Cryptogenic Stroke in the Young: Revealing the Etiology, Triggers, and Outcome
Enrolling by invitation NCT03373929 - Stitch Closure of PFO and Septal Repair N/A
Completed NCT02432131 - Decompression Sickness in Divers With or Without Patent Foramen Ovale
Recruiting NCT04881578 - Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study
Completed NCT02400892 - Patent Foramen Ovale and the Risk of Postoperative Delirium Following Elective Hip and Knee Arthroplasty Surgeries N/A
Recruiting NCT01385670 - InterSEPT: In‐Tunnel SeptRx European PFO Trial N/A
Completed NCT02957201 - The Effect on EPCs by Successful Cardiac Occlusion Device Implantation N/A
Completed NCT00968032 - Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System N/A
Recruiting NCT05558774 - Long-term Outcomes After Percutaneous Closure of PFO
Completed NCT02127294 - Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine N/A
Recruiting NCT01149447 - Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale N/A
Enrolling by invitation NCT05025475 - Stitch Closure of PFO and Septal Repair (STITCH) N/A
Suspended NCT04339699 - NobleStitch EL STITCH Trial is a PFO Comparative Trial N/A
Recruiting NCT04713683 - Investigation of Nickel Sensitization After Percutaneous Implantation of Patent Foramen Ovale Occluder N/A
Withdrawn NCT03232450 - Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation N/A