Pathophysiology and Risk of Atrial Fibrillation Detected After Ischemic Stroke

NCT03275155 | Active Not Recruiting

• 1 other identifier: R-17-032
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke, Ischemic; Transient Ischemic Attack; Atrial Fibrillation

Keywords

Autonomic Dysfunction; Inflammation; Cognitive impairment; Interoception; Gait impairment

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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

  At 14 days.

Secondary Outcomes (5)

• Biomarkers

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

• Atrial Fibrillation Burden

  At 14 days

• Gait Impairments

  At 6 months

• Frailty

  At 6 months

• Cognitive Impairment

  At 6 months

Other Outcomes (2)

• Stroke Recurrence

  At 90, 180, and 360 days

• Death

  At 90, 180, and 360 days

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Western University, Canada: collaborator
• London Health Sciences Centre: collaborator
• Parkwood Hospital, London, Ontario: collaborator
• El Instituto de Neurociencia Cognitiva y Traslacional (INCYT): collaborator
• Instituto de Neurologia Cognitiva (INECO): collaborator

Study Sites (1)

University Hospital, London Helath Sciences Center

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient; Atrial Fibrillation; Primary Dysautonomias; Inflammation; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Luciano A Sposato, MD

  Lawson Health Research Institute, London Health Sciences Center, Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: September 7, 2017
• Study Start: April 18, 2017
• Primary Completion: May 7, 2026
• Study Completion: May 7, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)