A Study to Determine if Identification of Undiagnosed Atrial Fibrillation in People at Least 70 Years of Age Reduces the Risk of Stroke

Completed · Phase 4

Conditions studied: Atrial Fibrillation, Atrial Flutter

In brief

The purpose of this study is to determine if an AF detection intervention in men and women at least 70 years of age with undiagnosed atrial fibrillation (AF) or atrial flutter (AFL) reduces the person-years incidence rate of stroke compared to usual care (no AF detection intervention).

Key facts

Study ID

NCT04126486

Run by

Bristol-Myers Squibb

People needed

11931

Starts

2019-12-17

Expected to finish

2023-06-30

Last updated by the study team

2023-07-12

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women at least 70 years of age who are new or established participants in the primary care practice
• Willing to provide consent to participate in the study and to use personal health information to ascertain endpoints from the Center for Medicare \& Medicaid Services (CMS) Medicare Claims Database and to access data from health records
• Health insurance by Medicare Parts A \& B (Medicare Fee-for-service)

You may not qualify if…

• Oral anticoagulation (OAC) for any indication at the time of enrollment
• History of Atrial Fibrillation (AF) or Atrial Flutter (AFL) as documented in the participant's current medical problem list
• Any condition the investigator considers a contraindication to OAC, e.g., bleeding that required medical attention or severe renal impairment
• 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
• Not able to wear the Zio®XT monitor or not able to apply the monitor by herself/himself or with the help of a caregiver
• Other protocol-defined inclusion/exclusion criteria could apply

Where it is running

• Local Institution - 0360 — Guntersville, Alabama, United States
• Local Institution - 0158 — Montgomery, Alabama, United States
• Local Institution - 0109 — Kingman, Arizona, United States
• Local Institution - 0047 — Peoria, Arizona, United States
• Local Institution - 0237 — Peoria, Arizona, United States
• Local Institution - 0171 — Phoenix, Arizona, United States
• Local Institution - 0271 — Phoenix, Arizona, United States
• Local Institution - 0323 — Yuma, Arizona, United States
• Local Institution - 0097 — Little Rock, Arkansas, United States
• Hope Clinical Research — Canoga Park, California, United States
• Local Institution - 0173 — Fremont, California, United States
• Local Institution - 0110 — Fullerton, California, United States
• Local Institution - 0301 — Oakland, California, United States
• Local Institution - 0248 — Sacramento, California, United States
• Local Institution - 0061 — Toluca Lake, California, United States
• Local Institution — Aventura, Florida, United States
• Local Institution - 0143 — Boynton Beach, Florida, United States
• Local Institution - 0232 — Clearwater, Florida, United States
• Local Institution - 0017 — Clearwater, Florida, United States
• Local Institution - 0062 — DeLand, Florida, United States
• University Clinical Research-Deland LLC dba Accel Research Sites — DeLand, Florida, United States
• Local Institution - 0350 — Doral, Florida, United States
• Local Institution - 0367 — Fort Lauderdale, Florida, United States
• Local Institution - 0161 — Fort Lauderdale, Florida, United States
• Local Institution - 0302 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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