Prospective Registry of Elderly ESUS With PFO

Embolic Stroke of Undetermined Source Clinical Trial

— COACH_ESUS  

Official title:

Prospective Registry of Elderly Patients With ESUS to Evaluate the Role of Covert Atrial Fibrillation and Patent Foramen Ovale

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05238610
• Other study ID #: COACH_ELDERLY_ESUS_NECA_2021
• Status: Recruiting
• Start date: January 17, 2022
• Est. completion date: May 31, 2027

Study information

• Verified date: February 2022
• Source: Asan Medical Center
• Contact: Sun U Kwon, MD. PhD
• Phone: 82-2-3010-3960
• Email: sukwon[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolic Stroke
• Embolic Stroke of Undetermined Source

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	National Evidence-Based Healthcare Collaborating Agency

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ischemic stroke recurrence	Time to occurrence of ischemic stroke after registration	at least 1 year
Secondary	MACE	Time to major cardiovascular event after registration	at least 1 year
Secondary	Hemorrhagic stroke	Time to hemorrhagic stroke after registration	at least 1 year
Secondary	Vascular death	Time to vascular death after registration	at least 1 year
Secondary	Myocardial infarction	Time to myocardial infarction	at least 1 year
Secondary	Atrial fibrillation after registration	Time to atrial fibrillation after registration	at least 1 year
Secondary	Atrial fibrillation lasting more than 2 or 6 min after registration	Time to atrial fibrillation lasting more than 2 or 6 min after registration	at least 1 year
Secondary	Major bleeding	Time to major bleeding event after registration	at least 1 year