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Completed

NCT Number: NCT02578979

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chia-yi Christian Hospital, Chiayi City, Taiwan

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Stroke symptoms within 2 days
  • Age ≥65 years

Exclusion criteria

  • History of atrial fibrillation or documented atrial fibrillation prior to randomization
  • Indication for oral anticoagulation at randomization
  • Absolute contraindication for oral anticoagulation at randomization
  • Intracerebral hemorrhage in medical history
  • Implanted pacemaker device or cardioverter/defibrillator
  • End stage renal disease

Treatment and study plan

Electrocardiogram

Device

Patients will receive electrocardiogram for detecting atrial fibrillation - a 5-day routine ECG.

Holter

Device

Patients will receive electrocardiogram for detecting atrial fibrillation - a 24-h Holter.

Primary outcomes

  1. Number of atrial fibrillation detected

    Time frame: within 3 month of stroke onset

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • Chiayi Christian Hospital
  • Dalin Tzu Chi General Hospital
  • National Taiwan University Hospital

Registry information

Official study title

Serial Electrocardiogram Versus Holter to Detect Atrial Fibrillation in Elderly Patients With Acute Ischemic Stroke: Study Protocol of a Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 19, 2015
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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