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CompletedNCT03275155PARADISEUpdated Sep 18, 2026

Pathophysiology and Risk of Atrial Fibrillation Detected After Ischemic Stroke

An observational study in Stroke, Ischemic, Transient Ischemic Attack and Atrial Fibrillation, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
45
Ages
18 Years and older
Sex
All
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Study summary

This prospective non-interventional cohort study investigates the pathophysiology of Atrial Fibrillation Detected After Stroke or transient ischemic attack (AFDAS) by comparing the autonomic function and inflammation between patients with AFDAS, patients with atrial fibrillation (AF) diagnosed before the ischemic event or known AF (KAF), and patients with normal sinus rhythm (NSR) after 14 day of cardiac monitoring following the event onset.

Read the detailed description

This study enrolls patients with acute ischemic stroke at the London Health Sciences Center in London, Ontario, Canada. The heart rhythm of the patients is monitored with a CardioSTAT® Holter device (Icentia) for 14 days after the ischemic event onset. Based on this cardiac monitoring and previous medical history, patients are stratified into three groups: (a) atrial fibrillation detected after stroke or transient ischemic attack (AFDAS), (b) atrial fibrillation diagnosed before the ischemic event or known AF (KAF), and (c) normal sinus rhythm (NSR).

Autonomic function is assessed by the levels of plasma catecholamines, a battery of validated autonomic tests [autonomic reflex screening (ARS)], heart rate variability (HRV) through data obtained by Holter monitoring by standard quantitative analysis methods according to the guidelines of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology and by the analysis of diurnal variation of heart rate. Blood samples are collected for the analysis of inflammatory markers (e.g. CRP, TNF-α, IL-1β, and IL-6), and potential AFDAS predictors such as brain natriuretic peptide (BNP- AFDAS biomarker), endothelin-1 (endothelial dysfunction marker), Lipoprotein(a) [Lp(a)] and thrombin-activatable fibrinolysis inhibitor (TAFI) plasma levels, TAFI activity, TAFI single nucleotide polymorphisms (SNPs), apo(a) isoform size and plasma catecholamines levels. Furthermore, specific neuroimaging findings (e.g., specific regions of the insula or its connections) and clinical features (e.g., impaired interoceptive processing, cognitive impairment, etc) are also analyzed. Interoception is assessed using a heartbeat detection task without feedback condition and gait, balance, frailty, and cognitive status in patients are evaluated by the administration of a battery of tests. Stroke recurrence will be assessed by a structured phone interview at 6 and 12 months after the initial stroke.

02

Conditions studied

  • Stroke, Ischemic
  • Transient Ischemic Attack
  • Atrial Fibrillation

Keywords

  • Autonomic Dysfunction
  • Inflammation
  • Cognitive impairment
  • Interoception
  • Gait impairment
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's enrollment of 45 is below the median of 300 across 771 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 331 studies on the registry; 137 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Ischemic stroke and transient ischemic attack patients presenting at the University Hospital of the London Health Science Center, London, Ontario, Canada.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. MCA territory- or -acute ischemic stroke patients seen in the Emergency Department or admitted to University Hospital, London, Ontario, Canada
  2. Age ≥ 18 years old
  3. Patient or Substitute Decision Maker must give written

Exclusion criteria

Exclusion Criteria:

  1. Patients with autonomic dysfunction such as Parkinson's disease that can be interfering with outcome assessment based on qualified investigator's judgment.
  2. Patients taking tricyclic antidepressant (TCAs)
  3. Patients in whom the acute stroke is primarily hemorrhagic
  4. Patients with both and atrial fibrillation
  5. Patients with both TIA and large vessel disease
  6. Patients with inflammatory diseases
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
45 participants (actual)
Patient registry
No

Groups and cohorts

  • AFDAS

    patients without history of atrial fibrillation before the qualifying stroke or transient ischemic attack who are diagnosed with atrial fibrillation during the 14 days of monitoring

  • KAF

    atrial fibrillation known before the stroke or transient ischemic attack

  • NSR

    patients without a history of atrial fibrillation who do not develop atrial fibrillation during the 14 days of cardiac monitoring

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What researchers measure

Primary outcomes

  1. Changes and Differences in Autonomic Function

    Differences in Composite Autonomic Severity Score (CASS) on an 11-point scale between patients with (a) AFDAS, (b) KAF , and (c) NSR

    Time frame: Within 48 hours of stroke onset and at 12, 30 and 90 days.

  2. Changes and Differences in Inflammatory Responses

    Differences in levels of plasma markers or temporal responses (CRP,TNFα, IL-6, IL-1β, etc) between patients with (a) AFDAS, (b)KAF and (c) NSR.

    Time frame: Within 48 hours of stroke onset and at 12, 30 and 90 days.

  3. Changes and Differences in Heart Rate Variability (HRV)

    Differences in HRV parameters between patients with (a) AFDAS, and (b) NSR

    Time frame: At 14 days.

Secondary outcomes

  1. Biomarkers

    Differences in levels of plasma markers (BNP,endothelin-1, Lp(a), and TAFI) or neuroimaging/clinical predictors between patients with (a) AFDAS , (b) KAF and (c) NSR

    Time frame: Within 48 hours of stroke onset, at 12, 30 and 90 days and at 6 months.

  2. Atrial Fibrillation Burden

    Difference in atrial fibrillation burden (sum of atrial fibrillation episodes for a period of time) of AFDAS subjects with mild stroke/TIA compared to AFDAS subjects with moderate/severe stroke.

    Time frame: At 14 days

  3. Gait Impairments

    Differences in gait parameters in patients with a) AFDAS , (b) KAF and (c) NSR.

    Time frame: At 6 months

  4. Frailty

    Differences in frailty in patients with (a) AFDAS , (b) KAF and (c) NSR

    Time frame: At 6 months

  5. Cognitive Impairment

    Differences in cognition in patients with (a) AFDAS , (b) KAF and (c) NSR

    Time frame: At 6 months

Other outcomes

  1. Stroke Recurrence

    Number of stroke recurrences in patients with (a) AFDAS , (b) KAF and (c) NSR

    Time frame: At 90, 180, and 360 days

  2. Death

    Number of deaths in (a) AFDAS , (b) KAF and (c) NSR groups

    Time frame: At 90, 180, and 360 days

07

Study locations

1 site
  • University Hospital, London Helath Sciences Center
    London, Ontario N6A 5A5, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2017 to primary completion in Apr 2019, 24 months.

Of 394 non-industry observational studies under Ischemic Stroke, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 140. This study's 24 months is below that.

Counting every sponsor, half of 436 studies reached it within 53 months; a quarter within 24 and three quarters within 127.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2017
First posted
Sep 7, 2017
StartActual
Apr 18, 2017
Primary completionActual
Apr 29, 2019
CompletionActual
Mar 26, 2020
Last update
Sep 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03275155
Collaborators
Western University, Canada, London Health Sciences Centre, Parkwood Hospital, London, Ontario, El Instituto de Neurociencia Cognitiva y Traslacional (INCYT), Instituto de Neurologia Cognitiva (INECO)
Responsible party
Sponsor
First posted
Sep 7, 2017
Start date
Apr 18, 2017
Primary completion
Apr 29, 2019
Completion
Mar 26, 2020
Last update
Sep 18, 2026

Study contacts

Luciano A Sposato, MD
principal investigator · Lawson Health Research Institute, London Health Sciences Center, Western University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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