Embolic Stroke of Undetermined Source
Conditions
Keywords
Embolic stroke of undetermined source, left ventricle enlargement, paroxysmal atrial fibrillation
Brief summary
The aim of the study is to evaluate the efficacy and safety of the Cardea SOLO Compared to 12 lead EKG for Paroxysmal Atrial Fibrillation Diagnosis in ESUS patients with Left Atrial Enlargement.
Detailed description
The Prospective, Multi-center, Open-label, Randomized, Controlled, Investigator-Initiated Trial will be started on June 2022. Randomized patients in two arms will receive Cardea SOLO or 12 lead EKG respectively. Cardea SOLO received patients will keep it for 7 days. 12 lead EKG received patients will discharge home. After 7 days, Results of Cardea SOLO auto reading will be evaluated by dependent committee including cardiologist.
Interventions
DEVICECardea SOLO
Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO
DEVICE12 Lead EKG
Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Prospective, Multi-center, Open-label, Randomized, Controlled, Investigator-Initiated Trial
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion NO. 3 or 4 must be satisfied, and No. 2, 5 and 6 must be satisfied. 2\. On the Screening date, Stroke onset date is not over 60 days. 3\. ESUS Diagnosis : all of a\ e must be satisfied. * a. Ischemic stroke detected by CT or MRI that is not lacunar * b. A person without arteriosclerosis which causes at least 50% stenosis of the intracranial/external arteries supplied to the ischemic site * c. During continuous monitoring or halter monitoring In the stroke intensive care unit, Person without atrial fibrillation and persistent atrial fibrillation * d. When checked the Transthoracic echocardiography, No major risk cardioembolic source of embolism. (ex. Myocardial infarction within 4 weeks, mitral stenosis, artificial heart valve and so on) * e. NO other specific cause of stroke identified(et, arteritis, dissection and drug abuse) 4\. cardioembolism is classified by TOAST classification. 5\. Left ventricle Enlargement(male \>40mm, female \>38mm, LAVI \>35ml/m2 6\. Voluntarily sign the consent form
Exclusion criteria
1. Transient cerebral ischemic attack 2. Active cancer 3. Heart embolism, stroke of major heart embolism, stroke high-risk disease 4. Left atrial thrombus 5. Left ventricular thrombus 6. Sick sinus syndrome 7. Myocardiac infarction in 1 month 8. Rheumatic left atrioventricular valve or aortic valve disease 9. Artificial heart valve 10. Myocardiac infarction (EF\<28%) 11. Congestive heart failure (EF\<30%) 12. Dilated cardiomyopathy 13. Nonbacterial thrombotic endocarditis 14. Endocarditis 15. Intracardiac mass 16. Atrial fibrillation 17. Restriction for echocardiography (obesity, lung disease etc) 18. High risk PFO 19. Patch apply difficulty(skin allergy, ulticaria, atopic dermatitis, hyperhidrosis) 20. Implant cardiac pacemaker 21. Life-threatening arrhythmia 22. Radiation therapy or MRI scan 23. Restriction for Cardia SOLO attachment 24. The person who investigator judged unsuitable for the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients number with AF over 30 seconds of cardea SOLO / with AF with 1 time of 12 lead EKG | 30 seconds | cardea SOLO and 12 lead EKG is different |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AF burden(F) | 1 week | cardea SOLO and 12 lead EKG is different |
| Number of other dysrhythmia | 1 week | cardea SOLO and 12 lead EKG is different |
Countries
South Korea
Outcome results
None listed