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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02578979 on ClinicalTrials.gov