StrokeNCT05822791
Differences in ECG- vs. proLonged cardIac MonItor-DeTected Atrial Fibrillation in STROKE Patients (DELIMIT AF-STROKE)
An observational study of Stroke and Atrial Fibrillation, run by Luciano A. Sposato at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Atrial Fibrillation, TIA
- What is being tested?
- Prolonged cardiac monitoring and ECG
- How many people
- 366 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2023to 20 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥18 years
- Patient with a diagnosis of ischemic stroke or TIA.
- ECG-diagnosed AF or PCM-detected AF post ischemic stroke or TIA
Who cannot join
- Individuals younger than18 years-old
- Patients without IS or TIA diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differences in ECG- vs. proLonged cardIac MonItor-DeTected Atrial Fibrillation in STROKE Patients
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.
Read the 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.
- Conditions
- Stroke, Atrial Fibrillation, TIA
- Being tested
- Prolonged cardiac monitoring, ECG
- Medical subject headings
- Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged cardiac monitoringDiagnostic test
Prolonged cardiac monitoring
ECGDiagnostic test
Electrocardiogram
| Study group | Role | What they receive |
|---|---|---|
| ECG-Detected AF | Patients with atrial fibrillation detected on 12-lead ECGs done post-stroke Receives: Diagnostic Test: ECG | |
| Device-Detected AF | Patients with atrial fibrillation detected on prolonged Holter monitoring lasting at least 7 days. Receives: Diagnostic Test: Prolonged cardiac monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Recurrent Ischemic Stroke at End of available Follow-up Time
Documented recurrent ischemic stroke
Measured: Duration of follow-up - minimum of 3 months after the first encounter with the stroke team
Secondary outcomes (3)
Death
Number of patients dead at the end of the available follow-up
Measured: Duration of follow-up - minimum of 3 months after the first encounter with the stroke team
Readmission for decompensated AF or heart failure
Prevalence of readmission for decompensated AF or heart failure (HF) in each group
Measured: 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
Proportion with vascular risk factors, cardiovascular comorbidities, and structural heart disease in each group
Measured: Documented at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 May 2023
- Primary completion20 Jul 2027 (estimated)
- Study completion20 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luciano A. Sposato
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luciano A. Sposato, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Luciano Sposato, MD, MBA (PI), Principal investigator, London Health Sciences Centre, Western University (London, ON. Canada)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822791
- Sponsor's protocol ID
- ReDA ID 13446
- Status last verified
- Sep 2026
- First submitted
- 31 Mar 2023
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patients data will be made available upon reasonable request, conditional to approval from Western University Ethics Review Board
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in ECG- vs. proLonged cardIac MonItor-DeTected Atrial Fibrillation in STROKE Patients
- ClinicalTrials.gov ID
- NCT05822791
- Acronym / sponsor ID
- ReDA ID 13446
- Conditions
- Stroke, Atrial Fibrillation, TIA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Luciano A. SposatoUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 20 Oct 2027 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECG-Detected AF | – | Diagnostic Test: ECGPatients with atrial fibrillation detected on 12-lead ECGs done post-stroke |
| Device-Detected AF | – | Diagnostic Test: Prolonged cardiac monitoringPatients with atrial fibrillation detected on prolonged Holter monitoring lasting at least 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥18 years
- Patient with a diagnosis of ischemic stroke or TIA.
- ECG-diagnosed AF or PCM-detected AF post ischemic stroke or TIA
Key exclusion criteria (2 listed)
- Individuals younger than18 years-old
- Patients without IS or TIA diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged cardiac monitoringProlonged cardiac monitoring | Diagnostic test | Device-Detected AF |
| ECGElectrocardiogram | Diagnostic test | ECG-Detected AF |
Primary outcome
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
3 secondary outcomes
Death
Time frame: Duration of follow-up - minimum of 3 months after the first encounter with the stroke team
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 risk factors, cardiovascular comorbidities, and structural heart disease
Time frame: Documented at baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No. Individual patients data will be made available upon reasonable request, conditional to approval from Western University Ethics Review Board
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciano Sposato, MD, MBA (PI) principal investigator
London Health Sciences Centre, Western University (London, ON. Canada)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Atrial Fibrillation, run by Luciano A. Sposato at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.