Differences in ECG- vs. proLonged cardIac MonItor-DeTected Atrial Fibrillation in STROKE Patients (DELIMIT AF-STROKE)

Active, not recruiting

• Conditions: Stroke; Atrial Fibrillation; TIA
• Interventions: Diagnostic Test: ECG; Diagnostic Test: Prolonged cardiac monitoring

• Registration Number: NCT05822791
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

The present study is an investigator-initiated, single-center, retrospective study based on data from the London Ontario Stroke Registry (LOSR), aiming to compare the characteristics and outcomes of ECG-detected and Device-Detected atrial fibrillation in patients with ischemic stroke and transient ischemic attack.

Detailed Description

Patients with ischemic stroke and transient ischemic attack (TIA) without known atrial fibrillation (AF) are investigated with Prolonged Cardiac Monitoring (PCM) to detect AF. It is unclear if AF detected on 12-lead ECG after stroke occurrence bears the same risk of stroke as Device-detected AF. The investigators hypothesize, that Device-detected AF has a lower risk of ischemic stroke recurrence. The investigators will conduct a retrospective analysis of prospectively collected data from consecutive patients enrolled in the London Ontario Stroke Registry, (Ontario, Canada). The primary outcome will be a recurrent ischemic stroke at the end of the available follow-up window. The investigators will include ischemic stroke and TIA patients with ECG-detected AF and those with Device-detected AF on at least 7 days of Holter monitoring.

Study Timeline

• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-04-20
• Study First Posted: 2023-04-21
• Study Start: 2023-05-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Primary Completion: 2024-10-20
• Study Completion: 2025-10-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 366

Inclusion Criteria

• Age ≥18 years
• Patient with a diagnosis of ischemic stroke or TIA.
• ECG-diagnosed AF or PCM-detected AF post ischemic stroke or TIA

Exclusion Criteria

• Individuals younger than18 years-old
• Patients without IS or TIA diagnosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ECG-Detected AF	ECG	Patients with atrial fibrillation detected on 12-lead ECGs done post-stroke
Device-Detected AF	Prolonged cardiac monitoring	Patients with atrial fibrillation detected on prolonged Holter monitoring lasting at least 7 days.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Recurrent Ischemic Stroke at End of available Follow-up Time	Duration of follow-up - minimum of 3 months after the first encounter with the stroke team	Documented recurrent ischemic stroke

Secondary Outcome Measures

Name	Time	Method
Prevalence of risk factors, cardiovascular comorbidities, and structural heart disease	Documented at baseline.	Proportion with vascular risk factors, cardiovascular comorbidities, and structural heart disease in each group
Death	Duration of follow-up - minimum of 3 months after the first encounter with the stroke team	Number of patients dead at the end of the available follow-up
Readmission for decompensated AF or heart failure	Duration of follow-up - minimum of 3 months after the first encounter with the stroke team	Prevalence of readmission for decompensated AF or heart failure (HF) in each group

Trial Locations

Locations (1)

Heart & Brain Lab, Western University; 🇨🇦 London, Ontario, Canada