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

Differences in ECG- vs. proLonged cardIac MonItor-DeTected Atrial Fibrillation in STROKE Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke; Atrial Fibrillation; TIA
• Intervention / Treatment: Diagnostic test: ECG; Diagnostic test: Prolonged cardiac monitoring

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 Type: Observational
• Enrollment (Estimated): 366

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • Heart & Brain Lab, Western University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with an acute ischemic stroke or TIA in the London Ontario Stroke Registry without known AF, who are newly diagnosed with AF on a 12-lead ECG or a ≥7-day external cardiac monitor.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ECG-Detected AF; Patients with atrial fibrillation detected on 12-lead ECGs done post-stroke	Diagnostic test: ECG; Electrocardiogram
Device-Detected AF; Patients with atrial fibrillation detected on prolonged Holter monitoring lasting at least 7 days.	Diagnostic test: Prolonged cardiac monitoring; Prolonged cardiac monitoring

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Luciano Sposato, MD, MBA (PI), London Health Sciences Centre, Western University (London, ON. Canada)

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): October 20, 2024
• Study Completion (Estimated): October 20, 2025

Study Registration Dates

• First Submitted: March 31, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Stroke; Atrial Fibrillation
• Other Study ID Numbers: ReDA ID 13446

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual patients data will be made available upon reasonable request, conditional to approval from Western University Ethics Review Board

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No