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A Study to Determine if Identification of Undiagnosed Atrial Fibrillation in People at Least 70 Years of Age Reduces the Risk of Stroke (1411907)
Overall Recruitment Status: Active, currently enrolling
 
Official Title
GUARD-AF: reducinG Stroke by Screening for UndiAgnosed atRial Fibrillation in Elderly inDividuals
 
Region Sponsors
California - Northern
Bristol-Myers Squibb Company
Pfizer
 
Acronym KP IRB No.
GUARD-AF) 1411907
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Older adults with no known history of AF or AFL.
 
Purpose
The purpose of this study is to determine if a one-time AF detection intervention using a continuous patch-based electrocardiographic monitor for up to 14 days in men and women at least 70 years of age without known atrial fibrillation (AF) or atrial flutter (AFL) reduces the person-years incidence rate of ischemic stroke compared to usual care.
 
Detailed Description
Randomized pragmatic clinical trial of one-time screening for AF using the Zio XT monitor decreases the risk of ischemic stroke compared with usual care among adults aged 70 years or older who do not a history of AF or AFL.
 
Gender Age Limit
Male & Female 70 years & older
 
Inclusion Criteria
  • Men and women at least 70 years of age in primary care practices
  • Willing to provide consent to participate in the study and to provide access to their data from health records
 
Exclusion Criteria
  • Oral anticoagulation (OAC) for any indication at the time of enrollment
  • History of atrial fibrillation or atrial flutter as documented in the participant's current medical problem list
  • Any condition the investigator considers a contraindication to OAC (for example, bleeding that required medical attention or severe kidney disease)
  • Any condition the investigator considers will prevent compliance with study instructions
  • Implanted cardiac devices (pacemakers, implantable cardiac defibrillators, or cardiac resynchronization therapy, and implantable loop recorders)
  • History of allergy to adhesive

 
Keywords and/or Specific Medical Conditions
  • Arrhythmias, Cardiac
  • Heart Diseases
  • Atrial Fibrillation
  • Ischemic Stroke
  • Atrial Flutter
  • Pathologic Processes
  • Cardiovascular Diseases
  • Cardiology
  • Electrocardiographic monitoring
 
KP Clinical Facility
  • All Kaiser Permanente Northern California Medical Centers
 
Clinical Area
  • Cardiology


Principal Investigator:
Alan S Go, MD
Contact Information:
- Thida C Tan, MPH
-thida.X.tan@kp.org
-Regional Locations-DOR


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