Prospective Registry of Elderly ESUS With PFO
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PFO closure.
- Who it may be relevant to
- Registry conditions: Embolic Stroke of Undetermined Source. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Registry of Elderly Patients With ESUS to Evaluate the Role of Covert Atrial Fibrillation and Patent Foramen Ovale
Overview
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
- Procedure PFO closure
PFO-closure will be performed after 3-6 month of observation and monitoring for paroxysmal atrial fibrillation
Primary outcome measures
- ischemic stroke recurrence [Time frame: at least 1 year]
Secondary outcome measures (7)
- MACE [Time frame: at least 1 year]
- Hemorrhagic stroke [Time frame: at least 1 year]
- Vascular death [Time frame: at least 1 year]
- Myocardial infarction [Time frame: at least 1 year]
- Atrial fibrillation after registration [Time frame: at least 1 year]
- Atrial fibrillation lasting more than 2 or 6 min after registration [Time frame: at least 1 year]
- Major bleeding [Time frame: at least 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
South Korea · 1 center
- Asan Medical Center — Seoul
Publications
- Kwon H, Lee PH, Song JK, Kwon SU, Kang DW, Kim JS. Patent Foramen Ovale Closure in Old Stroke Patients: A Subgroup Analysis of the DEFENSE-PFO Trial. J Stroke. 2021 May;23(2):289-292. doi: 10.5853/jos.2021.00647. Epub 2021 May 31. No abstract available. PMID 34102766
- Park S, Oh JK, Song JK, Kwon B, Kim BJ, Kim JS, Kang DW, Chang JY, Lee JS, Kwon SU. Transcranial Doppler as a Screening Tool for High-Risk Patent Foramen Ovale in Cryptogenic Stroke. J Neuroimaging. 2021 Jan;31(1):165-170. doi: 10.1111/jon.12783. Epub 2020 Sep 8. PMID 32896963
- Lee PH, Song JK, Kim JS, Heo R, Lee S, Kim DH, Song JM, Kang DH, Kwon SU, Kang DW, Lee D, Kwon HS, Yun SC, Sun BJ, Park JH, Lee JH, Jeong HS, Song HJ, Kim J, Park SJ. Cryptogenic Stroke and High-Risk Patent Foramen Ovale: The DEFENSE-PFO Trial. J Am Coll Cardiol. 2018 May 22;71(20):2335-2342. doi: 10.1016/j.jacc.2018.02.046. Epub 2018 Mar 12. PMID 29544871
- Kim BJ, Kim NY, Kang DW, Kim JS, Kwon SU. Provoked right-to-left shunt in patent foramen ovale associates with ischemic stroke in posterior circulation. Stroke. 2014 Dec;45(12):3707-10. doi: 10.1161/STROKEAHA.114.007453. Epub 2014 Oct 30. PMID 25358696
- Kim BJ, Sohn H, Sun BJ, Song JK, Kang DW, Kim JS, Kwon SU. Imaging characteristics of ischemic strokes related to patent foramen ovale. Stroke. 2013 Dec;44(12):3350-6. doi: 10.1161/STROKEAHA.113.002459. Epub 2013 Sep 26. PMID 24072002
- Jung JM, Lee JY, Kim HJ, Do Y, Kwon SU, Kim JS, Song JK, Kang DW. Patent foramen ovale and infarct volume in cryptogenic stroke. J Stroke Cerebrovasc Dis. 2013 Nov;22(8):1399-404. doi: 10.1016/j.jstrokecerebrovasdis.2013.04.034. Epub 2013 Jun 5. PMID 23747019
- Lee JY, Song JK, Song JM, Kang DH, Yun SC, Kang DW, Kwon SU, Kim JS. Association between anatomic features of atrial septal abnormalities obtained by omni-plane transesophageal echocardiography and stroke recurrence in cryptogenic stroke patients with patent foramen ovale. Am J Cardiol. 2010 Jul 1;106(1):129-34. doi: 10.1016/j.amjcard.2010.02.025. Epub 2010 May 13. PMID 20609660
Identifiers
NCT: NCT05238610 · COACH_ELDERLY_ESUS_NECA_2021