Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke
Completed · Phase 4
Conditions studied: Cryptogenic Symptomatic Transient Ischemic Attack, Cryptogenic Ischemic Stroke
In brief
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.
Key facts
- Study ID
- NCT00924638
- Run by
- Medtronic Cardiac Rhythm and Heart Failure
- People needed
- 447
- Starts
- 2009-06-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2014-07-28
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Recent cryptogenic symptomatic transient ischemic attack (TIA) or cryptogenic ischemic stroke.
You may not qualify if…
- 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.
Where it is running
- South Denver Cardiology / Swedish Medical Center — Denver, Colorado, United States
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- Iowa Heart / Ruan Neurology — Des Moines, Iowa, United States
- Louisville Cardiology — Louisville, Kentucky, United States
- Cardiology Associates Research, LLC — Tupelo, Mississippi, United States
- Mid America Heart Institute / St. Lukes Hospital — Kansas City, Missouri, United States
- Washington University Medical School — St Louis, Missouri, United States
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- Forsyth Medical Center — Winston-Salem, North Carolina, United States
- Ohio Health Research — Columbus, Ohio, United States
- Sacred Heart Medical Center — Eugene, Oregon, United States
- Central Bucks Specialists / Doylestown Hospital — Doylestown, Pennsylvania, United States
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States
- Lankenau — Wynnewood, Pennsylvania, United States
- Greenville Hospital System Cardiology/Cardiovascular Research — Greenville, South Carolina, United States
- St. Thomas Research Institute — Nashville, Tennessee, United States
- Baylor Research Institute — Dallas, Texas, United States
- University of Texas - Southwestern Medical Center — Dallas, Texas, United States
- LKH Universitätsklinikum Graz — Graz, Austria
- AKH Linz — Linz, Austria
- Landesklinikum Donauregion Tulln — Tulln, Austria
- UZ Antwerpen — Antwerp, Belgium
- Brussels Heart Center (St. Lean - St. Pierre) — Brussels, Belgium
- UZ Leuven — Leuven, Belgium
- El Camino Hospital — Mountain View, California, United States
Full record on ClinicalTrials.gov
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