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

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05822791
Collaborator
(none)
366
1
17.7
20.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Prolonged cardiac monitoring
  • Diagnostic Test: ECG

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
366 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Differences in ECG- vs. proLonged cardIac MonItor-DeTected Atrial Fibrillation in STROKE Patients
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Oct 20, 2023
Anticipated Study Completion Date :
Oct 20, 2024

Arms and Interventions

Arm Intervention/Treatment
ECG-Detected AF

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

Diagnostic Test: ECG
Electrocardiogram

Device-Detected AF

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

Diagnostic Test: Prolonged cardiac monitoring
Prolonged cardiac monitoring

Outcome Measures

Primary Outcome Measures

  1. Number of Participants with Recurrent Ischemic Stroke at End of available Follow-up Time [Duration of follow-up - minimum of 3 months after the first encounter with the stroke team]

    Documented recurrent ischemic stroke

Secondary Outcome Measures

  1. Death [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 [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 [Documented at baseline.]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Heart & Brain Lab, Western University London Ontario Canada N6A 5A5

Sponsors and Collaborators

  • Lawson Health Research Institute

Investigators

  • Principal Investigator: Luciano Sposato, MD, MBA (PI), London Health Sciences Centre, Western University (London, ON. Canada)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT05822791
Other Study ID Numbers:
  • ReDA ID 13446
First Posted:
Apr 21, 2023
Last Update Posted:
Apr 21, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2023