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

NCT ID: NCT05822791

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 366 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-10-20

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.

Conditions

Stroke; Atrial Fibrillation; TIA

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

ECG-Detected AF

Patients with atrial fibrillation detected on 12-lead ECGs done post-stroke

ECG

Intervention Type: DIAGNOSTIC_TEST

Electrocardiogram

Device-Detected AF

Patients with atrial fibrillation detected on prolonged Holter monitoring lasting at least 7 days.

Prolonged cardiac monitoring

Intervention Type: DIAGNOSTIC_TEST

Prolonged cardiac monitoring

Interventions

Prolonged cardiac monitoring

Prolonged cardiac monitoring

Intervention Type: DIAGNOSTIC_TEST

ECG

Electrocardiogram

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luciano Sposato, MD, MBA (PI)

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre, Western University (London, ON. Canada)

Locations

Heart & Brain Lab, Western University

London, Ontario, Canada

Countries

Canada

Other Identifiers

ReDA ID 13446

Identifier Type: -

Identifier Source: org_study_id