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

NCT05822791 | Active Not Recruiting

• 1 other identifier: ReDA ID 13446
• Study Type: observational
• Target: 366
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Atrial Fibrillation; TIA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Death

  Duration of follow-up - minimum of 3 months after the first encounter with the stroke team

• 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 risk factors, cardiovascular comorbidities, and structural heart disease

  Documented at baseline.

Study Arms (2)

ECG-Detected AF

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

Diagnostic Test: ECG

Device-Detected AF

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

Diagnostic Test: Prolonged cardiac monitoring

Interventions

Prolonged cardiac monitoring DIAGNOSTIC_TEST

Prolonged cardiac monitoring

Device-Detected AF

ECG DIAGNOSTIC_TEST

Electrocardiogram

ECG-Detected AF

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Heart & Brain Lab, Western University

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Stroke; Atrial Fibrillation

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Luciano Sposato, MD, MBA (PI)

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 21, 2023
• Study Start: May 1, 2023
• Primary Completion: October 20, 2024
• Study Completion: October 20, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)