Serial ECG Versus Holter to Detect Atrial Fibrillation in Elderly Ischemic Stroke Patients

Recruiting

Phase N/A Results N/A

Trial Description

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.

Detailed Description

Investigators plan to enroll 600 participants from six hospitals in Taiwan. Patients will be eligible for enrollment if they are admitted due to acute ischemic stroke within 7 days, with 20 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).

Conditions

Interventions

  • Electrocardiogram Procedure
    Intervention Desc: Patients will receive electrocardiogram for detecting atrial fibrillation - a 5-day routine ECG.
    ARM 1: Kind: Experimental
    Label: ECG for 5 days
    Description: Patients will receive 12-lead electrocardiogram for 5 days during their hospitalization.
  • Holter Device
    Intervention Desc: Patients will receive electrocardiogram for detecting atrial fibrillation - a 24-h Holter.
    ARM 1: Kind: Experimental
    Label: 24-h Holter
    Description: Patients will receive a 24-h Holter during their hospitalization.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Diagnostic
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of atrial fibrillation detected within 3 month of stroke onset No

Sponsors