Prospective Registry of Elderly ESUS With PFO
Recruiting · NCT05238610 · Observational (researchers observe without assigning treatment) · Lead sponsor: Asan Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
PFO closure
What this trial is about
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
Who can take part
Age range
60 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Patients older than 60 years-old
- Patients diagnosed as ESUS within 180 days from onset
- PFO found from TTE or TEE, which attributed to the ischemic stroke
- Patients or their legal representative agreed to participate
Exclusion criteria
- Patients with transient ischemic attack
- Patients with ischemic stroke at the vascular territory with significant stenosis
- Patients with high risk cardioembolic stroke detected from EKG, Holter monitoring or echocardiography
- Patients with other causes which may cause stroke (i.e. vasculitis, dissection, vasospasm, drug related or Moyamoya disease)
- Patients with active cancer
- Patients who need long term anticoagulation
- Patients who have side effect on antiplatelet treatment
- Patients with active internal bleeding
- Patients who refuse to participate
Where it is running
1 location listed.
- Asan Medical Center - Seoul, South Korea