Serial ECG Versus Holter to Detect Atrial Fibrillation in Elderly Ischemic Stroke Patients
NCT02578979 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 826
Last updated 2019-07-08
Summary
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.
Conditions
Interventions
- DEVICE
-
Electrocardiogram
Patients will receive electrocardiogram for detecting atrial fibrillation - a 5-day routine ECG.
- DEVICE
-
Holter
Patients will receive electrocardiogram for detecting atrial fibrillation - a 24-h Holter.
Sponsors & Collaborators
-
National Taiwan University Hospital
collaborator OTHER -
Chiayi Christian Hospital
collaborator OTHER -
Dalin Tzu Chi General Hospital
collaborator OTHER -
Chang Gung Memorial Hospital
lead OTHER
Principal Investigators
-
Meng Lee, MD · Chang Gung Memorial Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-10-01
- Primary Completion
- 2018-07-31
- Completion
- 2018-10-31
Countries
- Taiwan
Study Locations
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