Using 14-day Continuous Electrocardiography Patch Monitoring to Detect Paroxysmal Atrial Fibrillation After Stroke

NCT05218473 | Unknown

• 1 other identifier: 202101821B0C601
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this prospective, single-center, open-label, non-randomized, single- arm, historically controlled study, we will compare the detection rate of paroxysmal atrial fibrillation in acute ischemic stroke patients without known atrial fibrillation, using 14-day continuous electrocardiography patch monitoring, with a historical control group of patients who received serial 12-lead electrocardiograms once daily for five days or conventional 24-hour Holter monitoring. The study will be conducted in Chang Gung Memorial Hospital at Chiayi, Taiwan, from February 2022 to December 2024.

Conditions

Atrial Fibrillation; Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Paroxysmal atrial fibrillation

  The detection rate (%, percent) of new paroxysmal atrial fibrillation in each arm

  day 14

Study Arms (2)

Prolonged ECG monitoring group

EXPERIMENTAL

Patients receive 14-day continuous electrocardiography patch monitoring

Diagnostic Test: Prolonged ECG monitoring

Conventional procedure group

ACTIVE COMPARATOR

Patients received serial 12-lead electrocardiograms once daily for five days or 24-hour Holter monitoring

Diagnostic Test: Conventional procedure group

Interventions

Prolonged ECG monitoring DIAGNOSTIC_TEST

Using 14-day continuous electrocardiography patch monitoring to increase the detection rate of paroxysmal atrial fibrillation in acute ischemic stroke patients without known atrial fibrillation.

Prolonged ECG monitoring group

Conventional procedure group DIAGNOSTIC_TEST

Using serial 12-lead electrocardiograms once daily for five days or conventional 24-h Holter monitoring to detect new atrial fibrillation

Conventional procedure group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute ischemic stroke defined as an acute episode of neurological dysfunction caused by focal cerebral infarction and/or a corresponding lesion on brain imaging
• Stroke symptoms within 7 days
• Age ≥ 50 years
• At least one 12-lead ECG has already been obtained as part of the routine clinical workup after admisison, and no ECGs have shown any episodes of atrial fibrillation or atrial flutter

You may not qualify if:

• History of atrial fibrillation/atrial flutter or documented atrial fibrillation/atrial flutter prior to enrollment
• Intracerebral hemorrhage in medical history
• Implanted pacemaker device or cardioverter/defibrillator
• End stage renal disease
• Endocarditis
• Untreated hyperthyroidism
• Myocardial infarction or cardiac surgery less than one month prior to index stroke
• Any finding on echocardiography for which there is already an evidence-based indication for long-term anticoagulation (e.g. mechanical heart valve, thrombus, etc.)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Atrial Fibrillation; Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: This is an interventional study without concurrent controls. We will compare the detection rate of paroxysmal atrial fibrillation in acute ischemic stroke patients without known atrial fibrillation, using 14-day continuous ECG patch monitoring, with a historical control group of patients who received serial 12-lead ECGs or 24-hour Holter monitoring.

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: February 1, 2022
• Study Start: February 21, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 15, 2022

Record last verified: 2022-02