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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardea SOLO | Experimental | for 7 day holter monitor (patch type) |
|
| 12 Lead EKG | Active Comparator | (traditional EKG for under 2 minutes) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardea SOLO | Device | Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients number with AF over 30 seconds of cardea SOLO / with AF with 1 time of 12 lead EKG | cardea SOLO and 12 lead EKG is different | 30 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| AF burden(F) | cardea SOLO and 12 lead EKG is different | 1 week |
| Number of other dysrhythmia | cardea SOLO and 12 lead EKG is different |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BumJoon Kim | Seoul | South Korea |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Prospective, Multi-center, Open-label, Randomized, Controlled, Investigator-Initiated Trial
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| 12 Lead EKG | Device | Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO |
|
| 1 week |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D004568 | Electrodiagnosis |