Detection of Occult Paroxysmal Atrial Fibrillation After Stroke Using Prolonged Ambulatory Cardiac Monitoring

Study Overview
=================
Brief Summary
-----------------
About one-third of patients with stroke have no documented cause for the cerebrovascular event (known as cryptogenic strokes). Atrial fibrillation is a common cause of stroke, but when transient (paroxysmal) it may remain undiagnosed. Recent data suggest that occult paroxysmal atrial fibrillation may be identified in patients with cryptogenic strokes using prolonged ambulatory cardiac rhythm monitors. The investigators designed this study pursuing the following goals: To determine the prevalence of occult paroxysmal atrial fibrillation in patients with cryptogenic stroke using long-term mobile cardiac outpatient telemetry. To compare this prevalence to that found in a control group with stroke of known, non-cardioembolic cause. To look for clinical, laboratory, echocardiographic, and imaging data that serve as risk factors for occult paroxysmal atrial fibrillation in patients with cryptogenic stroke. To examine the utility of mobile cardiac outpatient telemetry, a relatively new diagnostic tool, in the evaluation of patients with cryptogenic stroke.

Official Title
-----------------
Detection of Occult Paroxysmal Atrial Fibrillation in Patients With Cryptogenic Stroke or TIA Using 21-Day Mobile Cardiac Outpatient Telemetry

Conditions
-----------------
Stroke, Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: Mobile cardiac rhythm monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stroke or TIA within previous 3 months Stroke work up including: EKG, serum lipids, serum TSH, TTE or TEE, brain CT and/or MRI, Vascular Evaluation of head and neck using any combination of ultrasound, MRA, CTA, and conventional angiography Exclusion Criteria: Documented history of atrial fibrillation or flutter PFO closure planned before conclusion of the monitoring period Incomplete stroke work up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cryptogenic stroke<br>Patients with stroke of unknown cause after comprehensive conventional evaluation | Other: Mobile cardiac rhythm monitoring<br>* Continuous ambulatory cardiac rhythm monitoring using the CardioNet MCOT device<br>|
| Stroke of known cause<br>Patients with stroke of known cause determined by comprehensive conventional evaluation | Other: Mobile cardiac rhythm monitoring<br>* Continuous ambulatory cardiac rhythm monitoring using the CardioNet MCOT device<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Atrial Fibrillation | Documented presence of atrial fibrillation detected by the monitoring device and independently confirmed by a board-certified cardiologist | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first episode of atrial fibrillation |  | Within monitoring period (3 weeks) | 
| Atrial Fibrillation Load | Total time that the patient had atrial fibrillation during the monitoring period | Within monitoring period (3 weeks) | 
| Adverse events related to mobile cardiac monitoring |  | 21 days | 
| Symptomatic status of episode of atrial fibrillation | Presence or absence of symptoms related to the occurrence of paroxysmal atrial fibrillation | 21 days | 
| Longest duration of episode of atrial fibrillation |  | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Atrial Fibrillation