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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05822791
• Other study ID #: ReDA ID 13446
• Status: Active, not recruiting
• Start date: May 1, 2023
• Est. completion date: October 20, 2025

Study information

• Verified date: March 2024
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 366
• Est. completion date: October 20, 2025
• Est. primary completion date: October 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke
• TIA

Intervention

Diagnostic Test:
• Prolonged cardiac monitoring
Prolonged cardiac monitoring
• ECG
Electrocardiogram

Locations

Country	Name	City	State
Canada	Heart & Brain Lab, Western University	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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.