Status:
RECRUITING
Prospective Registry of Elderly ESUS With PFO
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
National Evidence-Based Healthcare Collaborating Agency
Conditions:
Embolic Stroke of Undetermined Source
Eligibility:
All Genders
60+ years
Brief 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 un...
Detailed Description
The COACH-ELDERLY ESUS study is a multicenter, prospective, registry-based, observational study in elderly ESUS patients with high-risk PFO treated with PFO-closure + standard antiplatelet treatment o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 17 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT05238610
Start Date
January 17 2022
End Date
May 31 2027
Last Update
February 14 2022
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 05055