A Study to Determine if Identification of Undiagnosed Atrial Fibrillation in People at Least 70 Years of Age Reduces the Risk of Stroke
GUARD-AF
GUARD-AF: reducinG Stroke by Screening for UndiAgnosed atRial Fibrillation in Elderly inDividuals
1 other identifier
interventional
11,931
1 country
176
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 atrial-fibrillation
Started Dec 2019
Typical duration for phase_4 atrial-fibrillation
176 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2019
CompletedFirst Posted
Study publicly available on registry
October 15, 2019
CompletedStudy Start
First participant enrolled
December 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedJuly 12, 2023
July 1, 2023
3.5 years
October 11, 2019
July 10, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of all strokes leading to hospitalization
From 2.5 years to 5 years after study start
Incidence of bleeding leading to hospitalization
From 2.5 years to 5 years after study start
Study Arms (2)
Zio®XT Monitor Arm
OTHERUsual Care Arm
NO INTERVENTIONInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Pfizercollaborator
Study Sites (176)
Local Institution - 0302
Birmingham, Alabama, 35209, United States
Local Institution - 0360
Guntersville, Alabama, 35976, United States
Local Institution - 0158
Montgomery, Alabama, 36106, United States
Local Institution - 0109
Kingman, Arizona, 86409, United States
Local Institution - 0047
Peoria, Arizona, 85381, United States
Local Institution - 0237
Peoria, Arizona, 85381, United States
Local Institution - 0171
Phoenix, Arizona, 85004, United States
Local Institution - 0271
Phoenix, Arizona, 85051, United States
Local Institution - 0323
Yuma, Arizona, 85364, United States
Local Institution - 0097
Little Rock, Arkansas, 72204, United States
Hope Clinical Research
Canoga Park, California, 91303, United States
Local Institution - 0173
Fremont, California, 94538, United States
Local Institution - 0110
Fullerton, California, 92831, United States
Local Institution - 0301
Oakland, California, 94612, United States
Local Institution - 0248
Sacramento, California, 95821-2640, United States
Local Institution - 0061
Toluca Lake, California, 91602, United States
Local Institution
Aventura, Florida, 33180, United States
Local Institution - 0143
Boynton Beach, Florida, 33435, United States
Local Institution - 0232
Clearwater, Florida, 33756-2004, United States
Local Institution - 0017
Clearwater, Florida, 33761, United States
Local Institution - 0062
DeLand, Florida, 32720, United States
University Clinical Research-Deland LLC dba Accel Research Sites
DeLand, Florida, 32720, United States
Local Institution - 0350
Doral, Florida, 33166, United States
Local Institution - 0367
Fort Lauderdale, Florida, 33073, United States
Local Institution - 0161
Fort Lauderdale, Florida, 33308, United States
Vanguard Clinical Research, LLC
Fort Myers, Florida, 33907, United States
Finlay Medical Research Corp
Greenacres City, Florida, 33467, United States
Local Institution - 0348
Hialeah, Florida, 33012, United States
Local Institution - 0358
Hialeah, Florida, 33015, United States
Local Institution - 0219
Hialeah, Florida, 33016, United States
Local Institution - 0366
Jacksonville, Florida, 32204, United States
Local Institution - 0368
Jacksonville, Florida, 32216, United States
Local Institution - 0277
Jacksonville, Florida, 32224, United States
Local Institution - 0375
Lake City, Florida, 32055-4833, United States
Nova Clinical Research Center Inc
Miami, Florida, 33125, United States
Local Institution - 0025
Miami, Florida, 33144, United States
Local Institution - 0296
Miami, Florida, 33144, United States
Local Institution
Miami, Florida, 33155, United States
Local Institution
Miami, Florida, 33165, United States
Local Institution - 0300
Miami, Florida, 33174, United States
Local Institution - 0371
Miami, Florida, 33175, United States
Local Institution
Miami, Florida, 33176, United States
Local Institution - 0149
Miami Beach, Florida, 33140, United States
Local Institution - 0374
Miami Lakes, Florida, 33014, United States
Local Institution - 0372
Miami Shores, Florida, 33138, United States
Local Institution - 0010
Mt. Dora, Florida, 32757-9519, United States
Local Institution - 0058
Oviedo, Florida, 32765-4515, United States
Local Institution - 0132
Palm Harbor, Florida, 34684, United States
Local Institution - 0034
Palm Springs, Florida, 33406, United States
Local Institution - 0028
Tampa, Florida, 33613, United States
Local Institution - 0090
Tampa, Florida, 33615, United States
Local Institution - 0361
Weston, Florida, 33326, United States
Local Institution - 0263
Albany, Georgia, 31701, United States
Local Institution - 0027
Atlanta, Georgia, 30345, United States
Local Institution
Columbus, Georgia, 31904, United States
Local Institution - 0033
Eatonton, Georgia, 31024, United States
Local Institution - 0176
Fayetteville, Georgia, 30214, United States
Local Institution - 0214
Rincon, Georgia, 31406, United States
Local Institution - 0098
Savannah, Georgia, 31406, United States
Local Institution - 0123
Woodstock, Georgia, 30189, United States
Local Institution - 0311
Chicago, Illinois, 60637, United States
Local Institution - 0345
Evergreen Park, Illinois, 60805, United States
Local Institution - 0241
Gillespie, Illinois, 62033, United States
Local Institution - 0306
Wauconda, Illinois, 60084, United States
Local Institution - 0365
Indianapolis, Indiana, 46202, United States
Local Institution - 0254
Michigan City, Indiana, 46360-9330, United States
Local Institution - 0338
Ames, Iowa, 50010, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Local Institution - 0244
Wichita, Kansas, 67214, United States
Local Institution - 0369
Lexington, Kentucky, 40504, United States
Local Institution - 0133
Eunice, Louisiana, 70535, United States
Local Institution - 0321
New Orleans, Louisiana, 70121, United States
Local Institution - 0229
Zachary, Louisiana, 70791-4006, United States
Local Institution - 0351
Annapolis, Maryland, 21401, United States
Johns Hopkins
Baltimore, Maryland, 21287, United States
Local Institution - 0037
Elkridge, Maryland, 21075, United States
Local Institution - 0095
Rockville, Maryland, 20854, United States
Local Institution - 0284
Boston, Massachusetts, 02114, United States
Local Institution - 0051
Boston, Massachusetts, 02115, United States
Local Institution - 0333
Haverhill, Massachusetts, 01830, United States
Local Institution - 0201
New Bedford, Massachusetts, 02740, United States
Local Institution - 0227
Worcester, Massachusetts, 01655, United States
Local Institution - 0260
Caro, Michigan, 48723, United States
Local Institution - 0005
Detroit, Michigan, 48216, United States
Local Institution - 0166
Sterling Heights, Michigan, 48310, United States
Local Institution - 0257
Troy, Michigan, 48085, United States
Local Institution - 0256
Rochester, Minnesota, 55905-0001, United States
Belzoni Family Practice
Belzoni, Mississippi, 39038, United States
Local Institution - 0089
Jackson, Mississippi, 39209, United States
Local Institution - 0224
Petal, Mississippi, 39465, United States
Local Institution - 0060
Picayune, Mississippi, 39466, United States
Quinn Healthcare/SKYCRNG
Ridgeland, Mississippi, 39157, United States
Local Institution - 0116
St Louis, Missouri, 63123, United States
Local Institution - 0063
Norfolk, Nebraska, 68701, United States
Local Institution - 0222
Henderson, Nevada, 89014, United States
Local Institution
Las Vegas, Nevada, 89109, United States
Local Institution - 0334
Linden, New Jersey, 07036, United States
Local Institution - 0249
Brooklyn, New York, 11229, United States
Local Institution - 0362
Cooperstown, New York, 13326, United States
Local Institution
East Syracuse, New York, 13057, United States
Local Institution - 0102
Endwell, New York, 13760, United States
Local Institution - 0379
Niagara Falls, New York, 14304, United States
Digiovanna Institute For Medical Education
North Massapequa, New York, 11758, United States
Local Institution
Black Mountain, North Carolina, 28711, United States
Local Institution - 0328
Burlington, North Carolina, 27215, United States
Local Institution - 0164
Cary, North Carolina, 27615, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, 28209, United States
Local Institution - 0207
Charlotte, North Carolina, 28287, United States
Local Institution - 0006
Durham, North Carolina, 27701, United States
Local Institution
Fayetteville, North Carolina, 28304-3571, United States
Local Institution - 0268
Franklinton, North Carolina, 27525, United States
Local Institution - 0258
Greensboro, North Carolina, 27408, United States
Local Institution - 0159
Hickory, North Carolina, 28601, United States
Local Institution - 0331
Matthews, North Carolina, 28105, United States
Local Institution - 0230
Raleigh, North Carolina, 27609, United States
Local Institution - 0175
Rocky Mount, North Carolina, 27804, United States
Local Institution - 0253
Salisbury, North Carolina, 28144, United States
Local Institution - 0153
Statesville, North Carolina, 28625, United States
Local Institution - 0182
Statesville, North Carolina, 28625, United States
Local Institution - 0235
Wilmington, North Carolina, 28401-7307, United States
Local Institution - 0167
Winston-Salem, North Carolina, 27103-4109, United States
Sterling Research Group
Cincinnati, Ohio, 45219, United States
Local Institution - 0085
Cincinnati, Ohio, 45246, United States
Local Institution - 0283
Cleveland, Ohio, 44195, United States
Local Institution - 0036
Columbus, Ohio, 43213-3399, United States
Dayton Clinical Research
Dayton, Ohio, 45406, United States
Local Institution - 0212
Dayton, Ohio, 45419, United States
Local Institution - 0129
Philadelphia, Pennsylvania, 19107, United States
Local Institution - 0272
Pittsburgh, Pennsylvania, 15208, United States
Local Institution - 0236
Pittsburgh, Pennsylvania, 15236-4604, United States
Local Institution - 0349
Pittsburgh, Pennsylvania, 15243, United States
Local Institution - 0347
Uniontown, Pennsylvania, 15401, United States
Local Institution - 0370
Uniontown, Pennsylvania, 15401, United States
Local Institution - 0240
East Providence, Rhode Island, 02914, United States
Local Institution - 0155
Bristol, Tennessee, 37620, United States
Local Institution - 0234
Knoxville, Tennessee, 37912, United States
Local Institution - 0324
Morristown, Tennessee, 37813, United States
Local Institution - 0309
Nashville, Tennessee, 37212, United States
Wellness Clinical Research
Allen, Texas, 75013, United States
Local Institution - 0187
Austin, Texas, 78731, United States
Local Institution - 0243
Austin, Texas, 78745, United States
HRMD Research
Dallas, Texas, 75240, United States
Local Institution - 0242
Denton, Texas, 76210, United States
Invesclinic.U.S,LLC
Edinburg, Texas, 78539, United States
Local Institution - 0141
Friendswood, Texas, 77546, United States
Local Institution - 0354
Georgetown, Texas, 78628, United States
Local Institution - 0011
Houston, Texas, 77070, United States
Local Institution - 0343
Houston, Texas, 77095, United States
Local Institution - 0016
Hurst, Texas, 76054-3351, United States
Local Institution - 0151
Laredo, Texas, 78041, United States
Local Institution - 0170
Mesquite, Texas, 75149, United States
Local Institution - 0101
Pearland, Texas, 77584-7401, United States
Local Institution - 0223
Pflugerville, Texas, 78660, United States
Local Institution - 0303
Pharr, Texas, 78577, United States
Local Institution - 0204
Plano, Texas, 75025, United States
Local Institution - 0067
Plano, Texas, 75093, United States
SA Premiere Internal Medicine
San Antonio, Texas, 78220-2531, United States
Local Institution - 0092
San Antonio, Texas, 78249, United States
Local Institution - 0278
San Marcos, Texas, 78666-7579, United States
Local Institution - 0055
Sugar Land, Texas, 77479, United States
Local Institution - 0137
Sugar Land, Texas, 77479, United States
Local Institution - 0251
The Woodlands, Texas, 77382, United States
Local Institution - 0147
The Woodlands, Texas, 77384, United States
Local Institution - 0322
Tyler, Texas, 75702, United States
Local Institution - 0150
Bountiful, Utah, 84010, United States
Local Institution - 0339
Appomattox, Virginia, 24522, United States
Local Institution - 0191
Burke, Virginia, 22015, United States
Local Institution - 0340
Forest, Virginia, 24551, United States
Local Institution - 0267
Suffolk, Virginia, 23435, United States
Local Institution - 0096
Winchester, Virginia, 22601, United States
Local Institution - 0364
Winchester, Virginia, 22601, United States
Local Institution - 0086
Everett, Washington, 98208, United States
Local Institution - 0299
Tacoma, Washington, 98498, United States
Local Institution - 0337
Eau Claire, Wisconsin, 54703, United States
Local Institution - 0335
La Crosse, Wisconsin, 54601, United States
Local Institution - 0288
Madison, Wisconsin, 53715, United States
Related Publications (2)
Singer DE, Atlas SJ, Go AS, Lubitz SA, McManus DD, Dolor RJ, Chatterjee R, Rothberg MB, Rushlow DR, Crosson LA, Aronson RS, Mills D, Patlakh M, Gallup D, O'Brien EC, Lopes RD. Atrial Fibrillation Burden on a 14-Day ECG Monitor: Findings From the GUARD-AF Trial Screening Arm. JACC Clin Electrophysiol. 2025 Jan;11(1):110-119. doi: 10.1016/j.jacep.2024.08.010. Epub 2024 Sep 1.
PMID: 39297839DERIVEDLopes RD, Atlas SJ, Go AS, Lubitz SA, McManus DD, Dolor RJ, Chatterjee R, Rothberg MB, Rushlow DR, Crosson LA, Aronson RS, Patlakh M, Gallup D, Mills DJ, O'Brien EC, Singer DE. Effect of Screening for Undiagnosed Atrial Fibrillation on Stroke Prevention. J Am Coll Cardiol. 2024 Nov 19;84(21):2073-2084. doi: 10.1016/j.jacc.2024.08.019. Epub 2024 Sep 1.
PMID: 39230544DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2019
First Posted
October 15, 2019
Study Start
December 17, 2019
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
July 12, 2023
Record last verified: 2023-07