Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke
- Conditions
- Cryptogenic Ischemic StrokeCryptogenic Symptomatic Transient Ischemic Attack
- Interventions
- Device: Reveal® XT Insertable Cardiac Monitor
- Registration Number
- NCT00924638
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 447
- Recent cryptogenic symptomatic transient ischemic attack (TIA) or cryptogenic ischemic stroke.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continuous Monitoring Reveal® XT Insertable Cardiac Monitor Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor
- Primary Outcome Measures
Name Time Method AF Detection Rate Within 6 Months 6 months Percentage of subjects with AF detected within 6 months of follow-up
- Secondary Outcome Measures
Name Time Method AF Detection Rate Within 12 Months 12 months Percentage of subjects with AF detected within 12 months of follow-up
Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack) 12 months Percentage of subjects with recurrent stroke or TIA within 12 months of follow-up
Use of Oral Anticoagulation (OAC) Drugs 12 months Percentage of subjects who were using OAC drugs at the 12 months follow-up visit
Use of Antiarrhythmic Drugs 12 months Percentage of subjects who were using antiarrhythmic drugs at the 12 months follow-up visit
Health Outcome as Evaluated by EQ-5D Questionnaire 12 months 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).
Clinical Disease Burden and Care Pathway 12 months Incidence of cardiovascular (CV) or stroke/TIA related hospitalizations within 12 months
Impact of Patient Assistant Use on AF Diagnosis Follow-up closure AF detection lag (days from AF occurrence to AF diagnosis) characterized by patient assistant (PA) use frequency
Trial Locations
- Locations (55)
Baylor Research Institute
🇺🇸Dallas, Texas, United States
Iowa Heart / Ruan Neurology
🇺🇸Des Moines, Iowa, United States
Mid America Heart Institute / St. Lukes Hospital
🇺🇸Kansas City, Missouri, United States
Washington University Medical School
🇺🇸St. Louis, Missouri, United States
Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Ohio Health Research
🇺🇸Columbus, Ohio, United States
Central Bucks Specialists / Doylestown Hospital
🇺🇸Doylestown, Pennsylvania, United States
Lankenau
🇺🇸Wynnewood, Pennsylvania, United States
University of Texas - Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Landesklinikum Donauregion Tulln
🇦🇹Tulln, Austria
CHUS / Hopital Fleurimont
🇨🇦Sherbrooke, Quebec, Canada
Clinique Parly II - Centre Hospitalier de Versailles
🇫🇷Le Chesnay, France
Klinikum Coburg GmbH
🇩🇪Coburg, Bayern, Germany
Klinikum Dortmund
🇩🇪Dortmund, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
Asklepios Altona
🇩🇪Hamburg, Germany
UMG, Goettingen
🇩🇪Goettingen, Germany
Städtisches Klinikum Karlsruhe GmbH
🇩🇪Karlsruhe, Germany
Policlinico Universitario Agostino Gemelli
🇮🇹Rome, Italy
Ospedale Bolognini
🇮🇹Seriate, Italy
Atrium Medisch Centrum
🇳🇱Heerlen, Netherlands
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Hospital Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Spain
University Hospital Lund
🇸🇪Lund, Sweden
Cardiology Associates Research, LLC
🇺🇸Tupelo, Mississippi, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Asklepios Barmbek
🇩🇪Hamburg, Germany
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Greenville Hospital System Cardiology/Cardiovascular Research
🇺🇸Greenville, South Carolina, United States
Sacred Heart Medical Center
🇺🇸Eugene, Oregon, United States
LKH Universitätsklinikum Graz
🇦🇹Graz, Austria
AKH Linz
🇦🇹Linz, Austria
UZ Antwerpen
🇧🇪Antwerp, Belgium
Brussels Heart Center (St. Lean - St. Pierre)
🇧🇪Brussels, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Cliniques Universitaires UCL Mont-Godinne
🇧🇪Mont Godinne, Belgium
Hamilton Health Sciences / Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
Neurology clinic, Turku University Central Hospital
🇫🇮Turku, Finland
Hôpital Saint André -CHU de Bordeaux
🇫🇷Bordeaux, France
Hôpital de la Timone
🇫🇷Marseille, France
Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald
🇩🇪Greifswald, Germany
Henry Dunant General Hospital
🇬🇷Athens, Greece
Ospedale Misericordia di Grosseto
🇮🇹Grosseto, Italy
Knappschaftskrankenhaus Bochum
🇩🇪Bochum, Germany
Kreiskrankenhaus Rastatt
🇩🇪Rastatt, Germany
Ospedale di Imperia
🇮🇹Imperia, Italy
UMC Utrecht
🇳🇱Utrecht, Netherlands
NUSCH, a.s. Bratislava
🇸🇰Bratislava, Slovakia
VUSCH Kosice
🇸🇰Kosice, Slovakia
El Camino Hospital
🇺🇸Mountain View, California, United States
Louisville Cardiology
🇺🇸Louisville, Kentucky, United States
South Denver Cardiology / Swedish Medical Center
🇺🇸Denver, Colorado, United States
Skejby Hospital
🇩🇰Aarhus, Denmark
St. Thomas Research Institute
🇺🇸Nashville, Tennessee, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States