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| Name | Class |
|---|---|
| Korea Health Industry Development Institute | OTHER_GOV |
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It is known that atrial fibrillation after stroke significantly increases the risk of stroke or systemic embolism. Accordingly, efforts have been made to detect hidden atrial fibrillation and apply treatment using anticoagulants instead of antiplatelet agents. The conventional method used to screen for atrial fibrillation in stroke patients who did not have atrial fibrillation at first admission is 24-hour Holter monitoring. This study will compare the detection rate of atrial fibrillation with discontinuous ECG monitoring three times a day and 72 hours of single-lead ECG patch monitoring compared with the conventional Holter test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Holter Monitoring Group | Active Comparator | Holter monitoring is performed for 24 hours each at 1, 3, and 12 months after the diagnosis of stroke, and if atrial fibrillation is detected, the antiplatelet drug is changed to an anticoagulant. |
|
| Discontinuous Monitoring Group | Experimental | Discontinuous ECG monitoring by finger contact is performed 3 times every day for 12 months after a stroke diagnosis. If atrial fibrillation is detected, the antiplatelet drug is changed to an anticoagulant. |
|
| Single-lead Continuous Patch Group | Experimental | Continuous 72 hours of ECG monitoring by a single-lead patch is performed at a week and 1, 3, 6, 12 months after a stroke diagnosis. If atrial fibrillation is detected, the antiplatelet drug is changed to an anticoagulant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discontinuous monitoring | Device | Discontinuous ECG monitoring by finger contact every day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation detection rate | Compare detection rates of each arms | Until 1 year after stroke |
| Measure | Description | Time Frame |
|---|---|---|
| Change from antiplatelet therapy to anticoagulants following AF detection | Change from antiplatelet therapy to anticoagulants following AF detection | Until 1 year after stroke |
| Major adverse cardiac and cerebrovascular event |
| Measure | Description | Time Frame |
|---|---|---|
| Major bleeding | Fatal or overt bleeding with a drop in hemoglobin level of at least 2 g/dL or requiring transfusion of at least 2 units packed blood cells, or critical anatomical site hemorrhage (e.g., intracranial, retroperitoneal) | Until 1 year after stroke |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Junbeom Park, M.D., PhD. | Ewha Womans University Mokdong Hospital | Principal Investigator |
| Tae-Jin Song, MD | Ewha Womans University Seoul Hospital | Principal Investigator |
| Dong-Hyeok Kim, MD | Ewha Womans University Seoul Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Yongin Severance Hospital | Yongin | Gyeonggi-do | 17046 | South Korea | ||
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| Continuous single-lead ECG Patch | Device | Continuous 72hr ECG monitoring by a single-lead patch at 3, 6, 9, 12 months after stroke |
|
| 24-hour Holter monitoring | Device | Continuous 24-hour monitoring by Holter monitor at 1, 6, 12 month after stroke |
|
composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
| Until 1 year after stroke |
| Re-admission | Re-admission | Until 1 year after stroke |
| All-cause death | All-cause death | Until 1 year after stroke |
| Ewha Womans University Seoul Hospital |
| Gangseo |
| Seoul |
| 07985 |
| South Korea |
| Hanyang University Seoul Hospital | Seongdong | Seoul | 04763 | South Korea |
| Ewha Womans University Mokdong Hospital | Yangcheon | Seoul | 07985 | South Korea |
| Daegu Catholic University Medical Center | Daegu | South Korea |
| Gachon University Gil Hospital | Incheon | 21565 | South Korea |
| Kyung Hee University Hospital | Seoul | 02447 | South Korea |
| Yonsei University Health System, Severance Hospital | Seoul | 06273 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D000083242 | Ischemic Stroke |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002545 | Brain Ischemia |
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| ID | Term |
|---|---|
| D015716 | Electrocardiography, Ambulatory |
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |
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