Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke

Study Overview
=================
Brief Summary
-----------------
The 2006 American Heart Association / American Stroke Association Council on Stroke Guidelines for Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic recommended that patients with cryptogenic stroke take antithrombotic drugs (i.e. aspirin) in order to prevent a second stroke. When a stroke patient is found to have atrial fibrillation (AF), the guidelines recommend oral anticoagulation due to its superior efficacy over aspirin for stroke prevention. Physicians can best optimize the use of medicines only if they can precisely and correctly diagnose a patient's AF. The purpose of this study is to evaluate the time to first AF by 6 months' continuous rhythm monitoring versus control treatment in subjects with a recent cryptogenic stroke or Transient Ischemic Attack (TIA) without history of AF.

Official Title
-----------------
CRYptogenic STroke And underLying AF Trial

Conditions
-----------------
Cryptogenic Symptomatic Transient Ischemic Attack, Cryptogenic Ischemic Stroke

Intervention / Treatment
-----------------
* Device: Reveal® XT Insertable Cardiac Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recent cryptogenic symptomatic transient ischemic attack (TIA) or cryptogenic ischemic stroke. Exclusion Criteria: Known etiology of TIA or stroke. Untreated hyperthyroidism. Myocardial infarction less than 1 month prior to stroke or TIA. Coronary bypass grafting less than 1 month prior to stroke or TIA. Valvular disease requiring immediate surgical intervention. History of AF or atrial flutter. Patent Foramen Ovale (PFO) and PFO is or was an indication to start oral anticoagulation (OAC). Permanent indication for OAC at enrollment. Permanent contra-indication for OAC. Included in another clinical trial. Life expectancy less than 1 year. Pregnant. Indicated for Implantable Pulse Generator (IPG), Implantable Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT) or an implantable hemodynamic monitoring system. Not fit, unable or unwilling to follow the required procedures of the protocol.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous Monitoring<br>Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor | Device: Reveal® XT Insertable Cardiac Monitor<br>* The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.<br>* Other names: Reveal® XT;|
| No Intervention: Control Arm<br>Follow-up at the same frequency, but with no Insertable Cardiac Monitor | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF Detection Rate Within 6 Months | Percentage of subjects with AF detected within 6 months of follow-up | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF Detection Rate Within 12 Months | Percentage of subjects with AF detected within 12 months of follow-up | 12 months | 
| Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack) | Percentage of subjects with recurrent stroke or TIA within 12 months of follow-up | 12 months | 
| Use of Oral Anticoagulation (OAC) Drugs | Percentage of subjects who were using OAC drugs at the 12 months follow-up visit | 12 months | 
| Use of Antiarrhythmic Drugs | Percentage of subjects who were using antiarrhythmic drugs at the 12 months follow-up visit | 12 months | 
| Health Outcome as Evaluated by EQ-5D Questionnaire | EQ-5D VAS (visual analog scale) quality of life score, which is a continuous measure of quality of life ranging from 0 (worst) to 100 (perfect health). | 12 months | 
| Clinical Disease Burden and Care Pathway | Incidence of cardiovascular (CV) or stroke/TIA related hospitalizations within 12 months | 12 months | 
| Impact of Patient Assistant Use on AF Diagnosis | AF detection lag (days from AF occurrence to AF diagnosis) characterized by patient assistant (PA) use frequency | Follow-up closure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, cryptogenic stroke, continuous monitoring, implantable loop recorder, insertable cardiac monitor