Stroke, IschemicPARADISENCT03275155
Pathophysiology and Risk of Atrial Fibrillation Detected After Ischemic Stroke
An observational study of Stroke, Ischemic and Transient Ischemic Attack, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Transient Ischemic Attack, Atrial Fibrillation
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 18 Apr 2017to 26 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Ischemic stroke and transient ischemic attack patients presenting at the University Hospital of the London Health Science Center, London, Ontario, Canada.
Who may be able to join
- MCA territory-transient ischemic attack or -acute ischemic stroke patients seen in the Emergency Department or admitted to University Hospital, London, Ontario, Canada
- Age ≥ 18 years old
- Patient or Substitute Decision Maker must give written informed consent
Who cannot join
- Patients with autonomic dysfunction such as Parkinson's disease that can be interfering with outcome assessment based on qualified investigator's judgment.
- Patients taking tricyclic antidepressant (TCAs)
- Patients in whom the acute stroke is primarily hemorrhagic
- Patients with both TIA and atrial fibrillation
- Patients with both TIA and large vessel disease
- Patients with inflammatory diseases
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Hospital, London Helath Sciences Center
London, Ontario, N6A 5A5
About this study
Official title: The PAthophysiology and Risk of Atrial Fibrillation Detected After Ischemic StrokE (PARADISE): Prospective Non-interventional Cohort Study
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.
- Keywords
- Autonomic Dysfunction, Inflammation, Cognitive impairment, Interoception, Gait impairment
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient, Atrial Fibrillation, Primary Dysautonomias, Inflammation, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 48 hours of stroke onset and at 12, 30 and 90 days.
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.
Measured: Within 48 hours of stroke onset and at 12, 30 and 90 days.
Changes and Differences in Heart Rate Variability (HRV)
Differences in HRV parameters between patients with (a) AFDAS, and (b) NSR
Measured: At 14 days.
Secondary outcomes (5)
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
Measured: Within 48 hours of stroke onset, at 12, 30 and 90 days and at 6 months.
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.
Measured: At 14 days
Gait Impairments
Differences in gait parameters in patients with a) AFDAS , (b) KAF and (c) NSR.
Measured: At 6 months
Frailty
Differences in frailty in patients with (a) AFDAS , (b) KAF and (c) NSR
Measured: At 6 months
Cognitive Impairment
Differences in cognition in patients with (a) AFDAS , (b) KAF and (c) NSR
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start18 Apr 2017
- Primary completion29 Apr 2019
- Study completion26 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Luciano A Sposato, MD, Principal investigator, Lawson Health Research Institute, London Health Sciences Center, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275155
- Sponsor's protocol ID
- R-17-032
- Acronym
- PARADISE
- Status last verified
- Mar 2025
- First submitted
- 24 Aug 2017
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- The PAthophysiology and Risk of Atrial Fibrillation Detected After Ischemic StrokE (PARADISE): Prospective Non-interventional Cohort Study
- ClinicalTrials.gov ID
- NCT03275155
- Acronym / sponsor ID
- PARADISE / R-17-032
- Keywords
- Autonomic Dysfunction, Inflammation, Cognitive impairment, Interoception, Gait impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- 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)
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 7 Sep 2017 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ischemic stroke and transient ischemic attack patients presenting at the University Hospital of the London Health Science Center, London, Ontario, Canada.
Key inclusion criteria (3 listed)
- MCA territory-transient ischemic attack or -acute ischemic stroke patients seen in the Emergency Department or admitted to University Hospital, London, Ontario, Canada
- Age ≥ 18 years old
- Patient or Substitute Decision Maker must give written informed consent
Key exclusion criteria (6 listed)
- Patients with autonomic dysfunction such as Parkinson's disease that can be interfering with outcome assessment based on qualified investigator's judgment.
- Patients taking tricyclic antidepressant (TCAs)
- Patients in whom the acute stroke is primarily hemorrhagic
- Patients with both TIA and atrial fibrillation
- Patients with both TIA and large vessel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes and Differences in Autonomic Function
Time frame: Within 48 hours of stroke onset and at 12, 30 and 90 days.
Differences in Composite Autonomic Severity Score (CASS) on an 11-point scale between patients with (a) AFDAS, (b) KAF , and (c) NSR
Changes and Differences in Inflammatory Responses
Time frame: Within 48 hours of stroke onset and at 12, 30 and 90 days.
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.
Changes and Differences in Heart Rate Variability (HRV)
Time frame: At 14 days.
Differences in HRV parameters between patients with (a) AFDAS, and (b) NSR
5 secondary outcomes
Biomarkers
Time frame: Within 48 hours of stroke onset, at 12, 30 and 90 days and at 6 months.
Atrial Fibrillation Burden
Time frame: At 14 days
Gait Impairments
Time frame: At 6 months
Frailty
Time frame: At 6 months
Cognitive Impairment
Time frame: At 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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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 A Sposato, MD principal investigator
Lawson Health Research Institute, London Health Sciences Center, Western University
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, Ischemic and Transient Ischemic Attack, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 6 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes and Differences in Autonomic Function (time frame: Within 48 hours of stroke onset and at 12, 30 and 90 days.). The study lists 3 primary outcomes in all. 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.