Embolic Stroke of Undetermined Source
Conditions
Keywords
insertable loop recorder, patent foramen ovale, patent foramen ovale closure, elderly
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 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
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 or standard antiplatelet treatment only in 20 centers in Korea. Patients will receive an insertable loop recorder (ILR) to monitor paroxysmal atrial fibrillation. In cases, which are unavailable for ILR, recurrent EKG or Holter monitoring will be done based on the clinician's decision. Based on the attending physicians' decision with a multi-disciplinary approach, patients will receive PFO-closure with standard antiplatelet treatment or standard antiplatelet treatment only.
Interventions
PROCEDUREPFO closure
PFO-closure will be performed after 3-6 month of observation and monitoring for paroxysmal atrial fibrillation
Sponsors
National Evidence-Based Healthcare Collaborating Agency
Asan Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ischemic stroke recurrence | at least 1 year | Time to occurrence of ischemic stroke after registration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemorrhagic stroke | at least 1 year | Time to hemorrhagic stroke after registration |
| Vascular death | at least 1 year | Time to vascular death after registration |
| Myocardial infarction | at least 1 year | Time to myocardial infarction |
| MACE | at least 1 year | Time to major cardiovascular event after registration |
| Atrial fibrillation lasting more than 2 or 6 min after registration | at least 1 year | Time to atrial fibrillation lasting more than 2 or 6 min after registration |
| Major bleeding | at least 1 year | Time to major bleeding event after registration |
| Atrial fibrillation after registration | at least 1 year | Time to atrial fibrillation after registration |
Countries
South Korea
Contacts
Primary ContactSun U Kwon, MD. PhD
Backup ContactBum Joon Kim, MD PhD
Outcome results
None listed