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

July 4, 2019 updated by: Meng Lee, Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

826

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Chiayi City, Taiwan, 600
        • Chia-Yi Christian Hospital
      • Dalin, Taiwan, 622
        • Dalin Tzu Chi General Hospital
      • Keelung, Taiwan, 204
        • Chang Gung Memorial Hospital, Keelung Branch
      • Puzih, Taiwan, 613
        • Chang Gung Memorial Hospital, Chiayi Branch
      • Taipei City, Taiwan, 100
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital, Linkuo Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ECG for 5 days
Patients will receive 12-lead electrocardiogram for 5 days during their hospitalization.
Device: Electrocardiogram
Patients will receive electrocardiogram for detecting atrial fibrillation - a 5-day routine ECG.
Active Comparator: 24-h Holter
Patients will receive a 24-h Holter during their hospitalization.
Device: Holter
Patients will receive electrocardiogram for detecting atrial fibrillation - a 24-h Holter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of atrial fibrillation detected
Time Frame: within 3 month of stroke onset
within 3 month of stroke onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

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

Investigators

  • Principal Investigator: Meng Lee, MD, Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

July 31, 2018

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

October 12, 2015

First Submitted That Met QC Criteria

October 15, 2015

First Posted (Estimate)

October 19, 2015

Study Record Updates

Last Update Posted (Actual)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 4, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRPD1E0891

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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