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

Phase 4

Completed

• Conditions: Atrial Fibrillation; Atrial Flutter
• Interventions: Other: Zio®XT Monitor

• Registration Number: NCT04126486
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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).

Detailed Description

This a prospective, randomized study in primary care practices.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-15
• Study Start: 2019-12-17
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11931

Inclusion Criteria

• 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)

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zio®XT Monitor Arm	Zio®XT Monitor	-

Primary Outcome Measures

Name	Time	Method
Incidence of bleeding leading to hospitalization	From 2.5 years to 5 years after study start
Incidence of all strokes leading to hospitalization	From 2.5 years to 5 years after study start

Trial Locations

Locations (168)

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Dayton Clinical Research; 🇺🇸 Dayton, Ohio, United States

Local Institution - 0051; 🇺🇸 Boston, Massachusetts, United States

Local Institution - 0296; 🇺🇸 Miami, Florida, United States

Local Institution - 0047; 🇺🇸 Peoria, Arizona, United States

Local Institution - 0360; 🇺🇸 Guntersville, Alabama, United States

Local Institution - 0158; 🇺🇸 Montgomery, Alabama, United States

Local Institution - 0109; 🇺🇸 Kingman, Arizona, United States

Local Institution - 0237; 🇺🇸 Peoria, Arizona, United States

Local Institution - 0301; 🇺🇸 Oakland, California, United States

Local Institution - 0061; 🇺🇸 Toluca Lake, California, United States

Local Institution - 0143; 🇺🇸 Boynton Beach, 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 - 0161; 🇺🇸 Fort Lauderdale, Florida, United States

Local Institution - 0348; 🇺🇸 Hialeah, Florida, United States

Local Institution - 0368; 🇺🇸 Jacksonville, Florida, United States

Local Institution - 0358; 🇺🇸 Hialeah, Florida, United States

Local Institution - 0375; 🇺🇸 Lake City, Florida, United States

Local Institution - 0058; 🇺🇸 Oviedo, Florida, United States

Local Institution - 0300; 🇺🇸 Miami, Florida, United States

Local Institution - 0263; 🇺🇸 Albany, Georgia, United States

Local Institution - 0027; 🇺🇸 Atlanta, Georgia, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Local Institution - 0254; 🇺🇸 Michigan City, Indiana, United States

Local Institution - 0338; 🇺🇸 Ames, Iowa, United States

Local Institution - 0244; 🇺🇸 Wichita, Kansas, United States

Local Institution - 0037; 🇺🇸 Elkridge, Maryland, United States

Local Institution - 0095; 🇺🇸 Rockville, Maryland, United States

Local Institution - 0227; 🇺🇸 Worcester, Massachusetts, United States

Local Institution - 0333; 🇺🇸 Haverhill, Massachusetts, United States

Local Institution - 0201; 🇺🇸 New Bedford, Massachusetts, United States

Local Institution - 0060; 🇺🇸 Picayune, Mississippi, United States

Quinn Healthcare/SKYCRNG; 🇺🇸 Ridgeland, Mississippi, United States

Local Institution - 0212; 🇺🇸 Dayton, Ohio, United States

Local Institution - 0129; 🇺🇸 Philadelphia, Pennsylvania, United States

Local Institution - 0155; 🇺🇸 Bristol, Tennessee, United States

Local Institution - 0011; 🇺🇸 Houston, Texas, United States

Local Institution - 0251; 🇺🇸 The Woodlands, Texas, United States

Local Institution - 0150; 🇺🇸 Bountiful, Utah, United States

Local Institution - 0303; 🇺🇸 Pharr, Texas, United States

Local Institution - 0147; 🇺🇸 The Woodlands, Texas, United States

Local Institution - 0101; 🇺🇸 Pearland, Texas, United States

Local Institution - 0223; 🇺🇸 Pflugerville, Texas, United States

Local Institution - 0055; 🇺🇸 Sugar Land, Texas, United States

Local Institution - 0067; 🇺🇸 Plano, Texas, United States

Local Institution - 0299; 🇺🇸 Tacoma, Washington, United States

Local Institution - 0096; 🇺🇸 Winchester, Virginia, United States

Local Institution - 0137; 🇺🇸 Sugar Land, Texas, United States

Local Institution - 0322; 🇺🇸 Tyler, Texas, United States

Local Institution - 0339; 🇺🇸 Appomattox, Virginia, United States

Local Institution - 0267; 🇺🇸 Suffolk, Virginia, United States

Local Institution - 0191; 🇺🇸 Burke, Virginia, United States

Local Institution - 0340; 🇺🇸 Forest, Virginia, United States

Local Institution - 0337; 🇺🇸 Eau Claire, Wisconsin, United States

Local Institution - 0364; 🇺🇸 Winchester, Virginia, United States

Local Institution - 0086; 🇺🇸 Everett, Washington, United States

Local Institution - 0171; 🇺🇸 Phoenix, Arizona, United States

Local Institution - 0302; 🇺🇸 Birmingham, Alabama, United States

Local Institution - 0271; 🇺🇸 Phoenix, Arizona, United States

Local Institution - 0256; 🇺🇸 Rochester, Minnesota, United States

Local Institution - 0005; 🇺🇸 Detroit, Michigan, United States

SA Premiere Internal Medicine; 🇺🇸 San Antonio, Texas, United States

Local Institution - 0092; 🇺🇸 San Antonio, Texas, United States

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Local Institution - 0133; 🇺🇸 Eunice, Louisiana, United States

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Local Institution - 0116; 🇺🇸 Saint Louis, Missouri, United States

Local Institution - 0323; 🇺🇸 Yuma, Arizona, United States

Hope Clinical Research; 🇺🇸 Canoga Park, California, United States

Local Institution - 0110; 🇺🇸 Fullerton, California, United States

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Local Institution; 🇺🇸 Fayetteville, North Carolina, United States

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Local Institution - 0350; 🇺🇸 Doral, Florida, United States

Local Institution - 0367; 🇺🇸 Fort Lauderdale, Florida, United States

Vanguard Clinical Research, LLC; 🇺🇸 Fort Myers, Florida, United States

Finlay Medical Research Corp; 🇺🇸 Greenacres City, Florida, United States

Local Institution - 0277; 🇺🇸 Jacksonville, Florida, United States

Local Institution - 0219; 🇺🇸 Hialeah, Florida, United States

Local Institution - 0366; 🇺🇸 Jacksonville, Florida, United States

Nova Clinical Research Center Inc; 🇺🇸 Miami, Florida, United States

Local Institution - 0374; 🇺🇸 Miami Lakes, Florida, United States

Local Institution - 0149; 🇺🇸 Miami Beach, Florida, United States

Local Institution - 0372; 🇺🇸 Miami Shores, Florida, United States

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Local Institution - 0033; 🇺🇸 Eatonton, Georgia, United States

Local Institution - 0361; 🇺🇸 Weston, Florida, United States

Local Institution - 0311; 🇺🇸 Chicago, Illinois, United States

Local Institution - 0176; 🇺🇸 Fayetteville, Georgia, United States

Local Institution - 0098; 🇺🇸 Savannah, Georgia, United States

Local Institution - 0214; 🇺🇸 Rincon, Georgia, United States

Local Institution - 0345; 🇺🇸 Evergreen Park, Illinois, United States

Local Institution - 0365; 🇺🇸 Indianapolis, Indiana, United States

Local Institution - 0241; 🇺🇸 Gillespie, Illinois, United States

Local Institution - 0306; 🇺🇸 Wauconda, Illinois, United States

Local Institution - 0351; 🇺🇸 Annapolis, Maryland, United States

Local Institution - 0229; 🇺🇸 Zachary, Louisiana, United States

Local Institution - 0284; 🇺🇸 Boston, Massachusetts, United States

Local Institution - 0166; 🇺🇸 Sterling Heights, Michigan, United States

Local Institution - 0260; 🇺🇸 Caro, Michigan, United States

Local Institution - 0257; 🇺🇸 Troy, Michigan, United States

Belzoni Family Practice; 🇺🇸 Belzoni, Mississippi, United States

Local Institution - 0089; 🇺🇸 Jackson, Mississippi, United States

Local Institution - 0224; 🇺🇸 Petal, Mississippi, United States

Local Institution - 0063; 🇺🇸 Norfolk, Nebraska, United States

Local Institution - 0362; 🇺🇸 Cooperstown, New York, United States

Local Institution - 0222; 🇺🇸 Henderson, Nevada, United States

Local Institution - 0249; 🇺🇸 Brooklyn, New York, United States

Local Institution - 0334; 🇺🇸 Linden, New Jersey, United States

Local Institution - 0379; 🇺🇸 Niagara Falls, New York, United States

Local Institution - 0102; 🇺🇸 Endwell, New York, United States

Digiovanna Institute For Medical Education; 🇺🇸 North Massapequa, New York, United States

Local Institution - 0328; 🇺🇸 Burlington, North Carolina, United States

Local Institution - 0207; 🇺🇸 Charlotte, North Carolina, United States

Local Institution - 0164; 🇺🇸 Cary, North Carolina, United States

Local Institution - 0006; 🇺🇸 Durham, North Carolina, United States

PMG Research of Charlotte, LLC; 🇺🇸 Charlotte, North Carolina, United States

Local Institution - 0258; 🇺🇸 Greensboro, North Carolina, United States

Local Institution - 0268; 🇺🇸 Franklinton, North Carolina, United States

Local Institution - 0175; 🇺🇸 Rocky Mount, North Carolina, United States

Local Institution - 0331; 🇺🇸 Matthews, North Carolina, United States

Local Institution - 0230; 🇺🇸 Raleigh, North Carolina, United States

Local Institution - 0182; 🇺🇸 Statesville, North Carolina, United States

Sterling Research Group; 🇺🇸 Cincinnati, Ohio, United States

Local Institution - 0153; 🇺🇸 Statesville, North Carolina, United States

Local Institution - 0253; 🇺🇸 Salisbury, North Carolina, United States

Local Institution - 0235; 🇺🇸 Wilmington, North Carolina, United States

Local Institution - 0085; 🇺🇸 Cincinnati, Ohio, United States

Local Institution - 0283; 🇺🇸 Cleveland, Ohio, United States

Local Institution - 0036; 🇺🇸 Columbus, Ohio, United States

Local Institution - 0236; 🇺🇸 Pittsburgh, Pennsylvania, United States

Local Institution - 0272; 🇺🇸 Pittsburgh, Pennsylvania, United States

Local Institution - 0349; 🇺🇸 Pittsburgh, Pennsylvania, United States

Local Institution - 0347; 🇺🇸 Uniontown, Pennsylvania, United States

Local Institution - 0370; 🇺🇸 Uniontown, Pennsylvania, United States

Local Institution - 0240; 🇺🇸 East Providence, Rhode Island, United States

Local Institution - 0324; 🇺🇸 Morristown, Tennessee, United States

Local Institution - 0234; 🇺🇸 Knoxville, Tennessee, United States

Wellness Clinical Research; 🇺🇸 Allen, Texas, United States

Local Institution - 0309; 🇺🇸 Nashville, Tennessee, United States

Invesclinic.U.S,LLC; 🇺🇸 Edinburg, Texas, United States

HRMD Research; 🇺🇸 Dallas, Texas, United States

Local Institution - 0242; 🇺🇸 Denton, Texas, United States

Local Institution - 0016; 🇺🇸 Hurst, Texas, United States

Local Institution - 0354; 🇺🇸 Georgetown, Texas, United States

Local Institution - 0141; 🇺🇸 Friendswood, Texas, United States

Local Institution - 0343; 🇺🇸 Houston, Texas, United States

Local Institution - 0151; 🇺🇸 Laredo, Texas, United States

Local Institution - 0170; 🇺🇸 Mesquite, Texas, United States

Local Institution - 0248; 🇺🇸 Sacramento, California, United States

Local Institution - 0028; 🇺🇸 Tampa, Florida, United States

Local Institution - 0090; 🇺🇸 Tampa, Florida, United States

Local Institution - 0369; 🇺🇸 Lexington, Kentucky, United States

Local Institution - 0321; 🇺🇸 New Orleans, Louisiana, United States

Local Institution - 0167; 🇺🇸 Winston-Salem, North Carolina, United States

Local Institution - 0187; 🇺🇸 Austin, Texas, United States

Local Institution - 0243; 🇺🇸 Austin, Texas, United States

Local Institution - 0288; 🇺🇸 Madison, Wisconsin, United States

Local Institution - 0123; 🇺🇸 Woodstock, Georgia, United States

Local Institution - 0335; 🇺🇸 La Crosse, Wisconsin, United States