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

NCT02578979 | Completed

• 1 other identifier: NMRPD1E0891
• Study Type: interventional
• Target: 826
• Locations: 1 country
• Sites: 6

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.

Conditions

Ischemic Stroke

Keywords

atrial fibrillation; ischemic stroke; electrocardiogram; holter

Outcome Measures

Primary Outcomes (1)

• Number of atrial fibrillation detected

  within 3 month of stroke onset

Study Arms (2)

ECG for 5 days

EXPERIMENTAL

Patients will receive 12-lead electrocardiogram for 5 days during their hospitalization.

Device: Electrocardiogram

24-h Holter

ACTIVE COMPARATOR

Patients will receive a 24-h Holter during their hospitalization.

Device: Holter

Interventions

Electrocardiogram DEVICE

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

ECG for 5 days

Holter DEVICE

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

24-h Holter

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Taiwan University Hospital: collaborator
• Chiayi Christian Hospital: collaborator
• Dalin Tzu Chi General Hospital: collaborator

Study Sites (6)

Chia-yi Christian Hospital

Chiayi City, 600, Taiwan

Location

Dalin Tzu Chi General Hospital

Dalin, 622, Taiwan

Location

Chang Gung Memorial Hospital, Keelung Branch

Keelung, 204, Taiwan

Location

Chang Gung Memorial Hospital, Chiayi Branch

Puzih, 613, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Chang Gung Memorial Hospital, Linkuo Branch

Taoyuan District, 333, Taiwan

Location

Related Publications (2)

• Huang WY, Lee M, Sung SF, Tang SC, Chang KH, Huang YS, Lee JD, Lee TH, Jeng JS, Chung CM, Wu YL, Hsieh TT, Ovbiagele B. Atrial fibrillation trial to evaluate real-world procedures for their utility in helping to lower stroke events: A randomized clinical trial. Int J Stroke. 2021 Apr;16(3):300-310. doi: 10.1177/1747493020938297. Epub 2020 Jul 8.

  PMID: 32640882 DERIVED

• Hsieh TT, Lee M, Huang WY, Tang SC, Sung SF, Chang KH, Lee JD, Lee TH, Huang YS, Jeng JS, Chung CM, Wu YL, Ovbiagele B. Atrial fibrillation trial to evaluate real-world procedures for their utility in helping to lower stroke events (AFTER-PULSE): Study protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2017 Jun;6:127-130. doi: 10.1016/j.conctc.2017.04.005. Epub 2017 Apr 26.

  PMID: 29082335 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Atrial Fibrillation

Interventions

Electrocardiography; Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Meng Lee, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 19, 2015
• Study Start: October 1, 2015
• Primary Completion: July 31, 2018
• Study Completion: October 31, 2018
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (6)