Prospective Registry of Elderly ESUS With PFO

NCT05238610 · tracked via the Priya Life Science South Korea tracker

Sponsor

Asan Medical Center

Phase

Observational

Started

2022-01-17

Last updated

2022-02-14

Condition(s) studied

Embolic Stroke of Undetermined Source

Investigational drug(s) / intervention(s)

PFO closure

PFO closure: PFO-closure will be performed after 3-6 month of observation and monitoring for paroxysmal atrial fibrillation

Study summary

Patent foramen ovale (PFO) is associated with an increased risk of stroke. PFO-closure was effective in preventing stroke in young stroke patients less than age 60 presented as an embolic stroke of undetermined source (ESUS). However, the benefit of PFO-closure in elderly ESUS patients is not clear. The investigators designed this prospective register-based observational study to verify the efficacy of PFO-closure in elderly ESUS patients with high-risk PFO, older than 60 years

Eligibility

Sex

ALL

Min age

60 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Patients older than 60 years-old 2. Patients diagnosed as ESUS within 180 days from onset 3. PFO found from TTE or TEE, which attributed to the ischemic stroke 4. Patients or their legal representative agreed to participate Exclusion Criteria: 1. Patients with transient ischemic attack 2. Patients with ischemic stroke at the vascular territory with significant stenosis 3. Patients with high risk cardioembolic stroke detected from EKG, Holter monitoring or echocardiography 4. Patients with other causes which may cause stroke (i.e. vasculitis, dissection, vasospasm, drug related or Moyamoya disease) 5. Patients with active cancer 6. Patients who need long term anticoagulation 7. Patients who have side effect on antiplatelet treatment 8. Patients with active internal bleeding 9. Patients who refuse to participate

Primary outcome measure(s)

ischemic stroke recurrence — at least 1 year
Time to occurrence of ischemic stroke after registration

Trial sites (1)

Facility	City	Region	Status
Asan Medical Center	Seoul	South Korea	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05238610 on ClinicalTrials.gov ↗ ← All trials in South Korea