Pathophysiology and Risk of Atrial Fibrillation Detected After Ischemic Stroke "PARADISE"


Phase N/A Results N/A

Trial Description

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-╬▒, IL-1╬▓, 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.


Trial Population

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


Type Measure Time Frame Safety Issue
Primary Changes and Differences in Autonomic Function Within 48 hours of stroke onset and at 12, 30 and 90 days.
Primary Changes and Differences in Inflammatory Responses Within 48 hours of stroke onset and at 12, 30 and 90 days.
Primary Changes and Differences in Heart Rate Variability (HRV) At 14 days.
Secondary Biomarkers Within 48 hours of stroke onset, at 12, 30 and 90 days and at 6 months.
Secondary Atrial Fibrillation Burden At 14 days
Secondary Gait Impairments At 6 months
Secondary Frailty At 6 months
Secondary Cognitive Impairment At 6 months