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| Name | Class |
|---|---|
| National Taiwan University Hospital | OTHER |
| Chiayi Christian Hospital | OTHER |
| Dalin Tzu Chi General Hospital | OTHER |
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Paroxysmal atrial fibrillation is often undetected because characteristics such as short duration, episodic, and frequently asymptomatic nature make it challenging to diagnose at the bedside, leading to suboptimal secondary prevention. It is not uncommon for paroxysmal atrial fibrillation to be undetected in a single electrocardiogram (ECG) on admission. Conventional 24-hour Holter monitoring is often used to detect paroxysmal atrial fibrillation. However, systematic review suggests Holter monitoring will identify atrial fibrillation in only an additional 4.6% of patients, no better than detection rates observed in groups lacking routine monitoring. On the other hand, for ischemic stroke patients with sinus rhythm at baseline but paroxysmal atrial fibrillation still suspected, no recommendation beyond repeated 12-lead ECGs is made in the United Kingdom guideline. Serial 12-lead ECG has been used to detect possible paroxysmal atrial fibrillation among acute ischemic stroke patients and found 15 new cases of atrial fibrillation in 133 acute ischemic stroke patients (11.3%) without atrial fibrillation at baseline. The optimal investigation strategy, including modality, duration of investigation, and patient subgroup remains undefined, not only for efficacy in the detection of atrial fibrillation, but also cost-effectiveness in healthcare systems. The objective of this project is to conduct a pragmatic multicenter randomized controlled trial for the comparison of serial 12-lead ECG once daily for 5 days and 24-hour Holter to detect paroxysmal atrial fibrillation in acute ischemic stroke patients without atrial fibrillation identified by baseline ECG or history.
Investigators plan to enroll 900 participants from six hospitals in Taiwan. Patients will be eligible for enrollment if they are admitted due to acute ischemic stroke within 2 days, with 65 years of age or older, do not have known atrial fibrillation on history or baseline ECG at admission. Investigators will randomly assigned participants in a 1:1 ratio to undergo daily 12-lead ECG once daily for 5 days (intervention group) or 24-hour Holter monitoring (control group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECG for 5 days | Experimental | Patients will receive 12-lead electrocardiogram for 5 days during their hospitalization. |
|
| 24-h Holter | Active Comparator | Patients will receive a 24-h Holter during their hospitalization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrocardiogram | Device | Patients will receive electrocardiogram for detecting atrial fibrillation - a 5-day routine ECG. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of atrial fibrillation detected | within 3 month of stroke onset |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meng Lee, MD | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chia-yi Christian Hospital | Chiayi City | 600 | Taiwan | |||
| Dalin Tzu Chi General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32640882 | Derived | Huang WY, Lee M, Sung SF, Tang SC, Chang KH, Huang YS, Lee JD, Lee TH, Jeng JS, Chung CM, Wu YL, Hsieh TT, Ovbiagele B. Atrial fibrillation trial to evaluate real-world procedures for their utility in helping to lower stroke events: A randomized clinical trial. Int J Stroke. 2021 Apr;16(3):300-310. doi: 10.1177/1747493020938297. Epub 2020 Jul 8. | |
| 29082335 |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D015716 | Electrocardiography, Ambulatory |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Holter | Device | Patients will receive electrocardiogram for detecting atrial fibrillation - a 24-h Holter. |
|
| Dalin |
| 622 |
| Taiwan |
| Chang Gung Memorial Hospital, Keelung Branch | Keelung | 204 | Taiwan |
| Chang Gung Memorial Hospital, Chiayi Branch | Puzih | 613 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Chang Gung Memorial Hospital, Linkuo Branch | Taoyuan | 333 | Taiwan |
| Hsieh TT, Lee M, Huang WY, Tang SC, Sung SF, Chang KH, Lee JD, Lee TH, Huang YS, Jeng JS, Chung CM, Wu YL, Ovbiagele B. Atrial fibrillation trial to evaluate real-world procedures for their utility in helping to lower stroke events (AFTER-PULSE): Study protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2017 Jun;6:127-130. doi: 10.1016/j.conctc.2017.04.005. Epub 2017 Apr 26. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |