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

Not Applicable

Completed

• Conditions: Ischemic Stroke
• Interventions: Device: Electrocardiogram; Device: Holter

• Registration Number: NCT02578979
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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.

Detailed Description

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).

Study Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-19
• Primary Completion: 2018-07-31
• Study Completion: 2018-10-31
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-04
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 826

Inclusion Criteria

1. Cerebral ischemia defined as stroke (sudden focal neurologic deficit lasting >24 h consistent with the territory of a major cerebral artery and categorized as ischemic) and/or a corresponding lesion on brain imaging
2. Stroke symptoms within 2 days
3. Age ≥65 years

Exclusion Criteria

1. History of atrial fibrillation or documented atrial fibrillation prior to randomization
2. Indication for oral anticoagulation at randomization
3. Absolute contraindication for oral anticoagulation at randomization
4. Intracerebral hemorrhage in medical history
5. Implanted pacemaker device or cardioverter/defibrillator
6. End stage renal disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ECG for 5 days	Electrocardiogram	Patients will receive 12-lead electrocardiogram for 5 days during their hospitalization.
24-h Holter	Holter	Patients will receive a 24-h Holter during their hospitalization.

Primary Outcome Measures

Name	Time	Method
Number of atrial fibrillation detected	within 3 month of stroke onset

Trial Locations

Locations (6)

Chia-yi Christian Hospital; 🇨🇳 Chiayi City, Taiwan

Chang Gung Memorial Hospital, Chiayi Branch; 🇨🇳 Puzih, Taiwan

Chang Gung Memorial Hospital, Linkuo Branch; 🇨🇳 Taoyuan, Taiwan

Chang Gung Memorial Hospital, Keelung Branch; 🇨🇳 Keelung, Taiwan

Dalin Tzu Chi General Hospital; 🇨🇳 Dalin, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei City, Taiwan