Clinical trial NCT05822791: Differences in ECG- vs. proLonged cardIac MonItor-DeTected Atrial Fibrillation in STROKE Patients (DELIMIT AF-STROKE)
Official title: Differences in ECG- vs. proLonged cardIac MonItor-DeTected Atrial Fibrillation in STROKE Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stroke
Atrial Fibrillation
TIA
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Number of Participants with Recurrent Ischemic Stroke at End of available Follow-up Time
timeFrame: Duration of follow-up - minimum of 3 months after the first encounter with the stroke team
Secondary outcomes:
measure: Death
timeFrame: Duration of follow-up - minimum of 3 months after the first encounter with the stroke team
measure: Readmission for decompensated AF or heart failure
timeFrame: Duration of follow-up - minimum of 3 months after the first encounter with the stroke team
measure: Prevalence of risk factors, cardiovascular comorbidities, and structural heart disease
timeFrame: Documented at baseline.
Other outcomes:
Locations:
city: London
country: Canada
facility: Heart & Brain Lab, Western University
state: Ontario
Study officials:
affiliation: London Health Sciences Centre, Western University (London, ON. Canada)
name: Luciano Sposato, MD, MBA (PI)
role: PRINCIPAL_INVESTIGATOR
References: