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OpenTrials
Active, not recruiting

NCT Number: NCT05822791

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart & Brain Lab, Western University

London, Ontario, N6A 5A5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prolonged cardiac monitoring

Diagnostic Test

Prolonged cardiac monitoring

ECG

Diagnostic Test

Electrocardiogram

Primary outcomes

  1. Number of Participants with Recurrent Ischemic Stroke at End of available Follow-up Time

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

    Documented recurrent ischemic stroke

Secondary outcomes

  1. Death

    Time frame: 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

  2. Readmission for decompensated AF or heart failure

    Time frame: 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

  3. Prevalence of risk factors, cardiovascular comorbidities, and structural heart disease

    Time frame: Documented at baseline.

    Proportion with vascular risk factors, cardiovascular comorbidities, and structural heart disease in each group

Sponsors and collaborators

Lead sponsor

Luciano A. Sposato

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 21, 2023
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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