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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02578979
• Other study ID #: NMRPD1E0891
• Status: Completed
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: October 31, 2018

Study information

• Verified date: July 2019
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 826
• Est. completion date: October 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• Electrocardiogram
Patients will receive electrocardiogram for detecting atrial fibrillation - a 5-day routine ECG.
• Holter
Patients will receive electrocardiogram for detecting atrial fibrillation - a 24-h Holter.

Locations

Country	Name	City	State
Taiwan	Chia-yi Christian Hospital	Chiayi City
Taiwan	Dalin Tzu Chi General Hospital	Dalin
Taiwan	Chang Gung Memorial Hospital, Keelung Branch	Keelung
Taiwan	Chang Gung Memorial Hospital, Chiayi Branch	Puzih
Taiwan	National Taiwan University Hospital	Taipei City
Taiwan	Chang Gung Memorial Hospital, Linkuo Branch	Taoyuan

Sponsors (4)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Chiayi Christian Hospital, Dalin Tzu Chi General Hospital, National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of atrial fibrillation detected		within 3 month of stroke onset