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

NCT04126486

Last updated date
Study Location
Local Institution
Miami, Florida, 33155, United States
Contact
please email:

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atrial Fibrillation, Atrial Flutter
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
70 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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


Other protocol-defined inclusion/exclusion criteria could apply

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Atrial Fibrillation, Atrial FlutterA Study to Determine if Identification of Undiagnosed Atrial Fibrillation in People at Least 70 Years of Age Reduces the Risk of Stroke
NCT04126486
  1. Miami, Florida
  2. Rincon, Georgia
  3. Wichita, Kansas
  4. Zachary, Louisiana
  5. Birmingham, Alabama
  6. Guntersville, Alabama
  7. Huntsville, Alabama
  8. Montgomery, Alabama
  9. Kingman, Arizona
  10. Peoria, Arizona
  11. Peoria, Arizona
  12. Phoenix, Arizona
  13. Phoenix, Arizona
  14. Yuma, Arizona
  15. Little Rock, Arkansas
  16. Canoga Park, California
  17. Fremont, California
  18. Fullerton, California
  19. Los Angeles, California
  20. Mission Viejo, California
  21. Oakland, California
  22. Palm Springs, California
  23. Sacramento, California
  24. Sacramento, California
  25. Toluca Lake, California
  26. Aurora, Colorado
  27. Colorado Springs, Colorado
  28. Aventura, Florida
  29. Boynton Beach, Florida
  30. Clearwater, Florida
  31. Clearwater, Florida
  32. DeLand, Florida
  33. DeLand, Florida
  34. Doral, Florida
  35. Doral, Florida
  36. Doral, Florida
  37. Eustis, Florida
  38. Fort Lauderdale, Florida
  39. Fort Lauderdale, Florida
  40. Fort Myers, Florida
  41. Hialeah, Florida
  42. Hialeah, Florida
  43. Hialeah, Florida
  44. Jacksonville, Florida
  45. Miami Beach, Florida
  46. Miami Lakes, Florida
  47. Miami Shores, Florida
  48. Miami, Florida
  49. Miami, Florida
  50. Miami, Florida
  51. Miami, Florida
  52. Miami, Florida
  53. Miami, Florida
  54. Miami, Florida
  55. Miami, Florida
  56. Miami, Florida
  57. Mount Dora, Florida
  58. Oviedo, Florida
  59. Palm Harbor, Florida
  60. Palm Springs, Florida
  61. Sweetwater, Florida
  62. Tampa, Florida
  63. Tampa, Florida
  64. Albany, Georgia
  65. Atlanta, Georgia
  66. Columbus, Georgia
  67. Eatonton, Georgia
  68. Fayetteville, Georgia
  69. Sandy Springs, Georgia
  70. Savannah, Georgia
  71. Woodstock, Georgia
  72. Chicago, Illinois
  73. Evergreen Park, Illinois
  74. Gillespie, Illinois
  75. Wauconda, Illinois
  76. Indianapolis, Indiana
  77. Michigan City, Indiana
  78. Ames, Iowa
  79. Iowa City, Iowa
  80. Leawood, Kansas
  81. Lexington, Kentucky
  82. Crowley, Louisiana
  83. Eunice, Louisiana
  84. New Orleans, Louisiana
  85. Shreveport, Louisiana
  86. Annapolis, Maryland
  87. Baltimore, Maryland
  88. Elkridge, Maryland
  89. Hyattsville, Maryland
  90. Rockville, Maryland
  91. Boston, Massachusetts
  92. Boston, Massachusetts
  93. Boston, Massachusetts
  94. Haverhill, Massachusetts
  95. New Bedford, Massachusetts
  96. Worcester, Massachusetts
  97. Caro, Michigan
  98. Detroit, Michigan
  99. Sterling Heights, Michigan
  100. Troy, Michigan
  101. Minneapolis, Minnesota
  102. Amory, Mississippi
  103. Belzoni, Mississippi
  104. Jackson, Mississippi
  105. Picayune, Mississippi
  106. Ridgeland, Mississippi
  107. Chesterfield, Missouri
  108. Florissant, Missouri
  109. Saint Louis, Missouri
  110. Norfolk, Nebraska
  111. Las Vegas, Nevada
  112. Linden, New Jersey
  113. Brooklyn, New York
  114. Cooperstown, New York
  115. East Syracuse, New York
  116. Endwell, New York
  117. North Massapequa, New York
  118. Black Mountain, North Carolina
  119. Burlington, North Carolina
  120. Cary, North Carolina
  121. Charlotte, North Carolina
  122. Charlotte, North Carolina
  123. Charlotte, North Carolina
  124. Durham, North Carolina
  125. Fayetteville, North Carolina
  126. Franklinton, North Carolina
  127. Greensboro, North Carolina
  128. Hickory, North Carolina
  129. Matthews, North Carolina
  130. Raleigh, North Carolina
  131. Raleigh, North Carolina
  132. Rocky Mount, North Carolina
  133. Salisbury, North Carolina
  134. Statesville, North Carolina
  135. Statesville, North Carolina
  136. Wilmington, North Carolina
  137. Winston-Salem, North Carolina
  138. Winston-Salem, North Carolina
  139. Cincinnati, Ohio
  140. Cincinnati, Ohio
  141. Cincinnati, Ohio
  142. Cleveland, Ohio
  143. Columbus, Ohio
  144. Dayton, Ohio
  145. Dayton, Ohio
  146. Norman, Oklahoma
  147. Danville, Pennsylvania
  148. Philadelphia, Pennsylvania
  149. Pittsburgh, Pennsylvania
  150. Pittsburgh, Pennsylvania
  151. Pittsburgh, Pennsylvania
  152. Uniontown, Pennsylvania
  153. Uniontown, Pennsylvania
  154. East Providence, Rhode Island
  155. Bristol, Tennessee
  156. Chattanooga, Tennessee
  157. Knoxville, Tennessee
  158. Morristown, Tennessee
  159. Nashville, Tennessee
  160. Allen, Texas
  161. Austin, Texas
  162. Dallas, Texas
  163. Dallas, Texas
  164. Denton, Texas
  165. Edinburg, Texas
  166. Friendswood, Texas
  167. Georgetown, Texas
  168. Houston, Texas
  169. Houston, Texas
  170. Hurst, Texas
  171. Laredo, Texas
  172. Mesquite, Texas
  173. Pearland, Texas
  174. Pflugerville, Texas
  175. Pharr, Texas
  176. Plano, Texas
  177. Plano, Texas
  178. San Antonio, Texas
  179. San Antonio, Texas
  180. San Marcos, Texas
  181. Sugar Land, Texas
  182. Sugar Land, Texas
  183. Temple, Texas
  184. The Woodlands, Texas
  185. The Woodlands, Texas
  186. Tyler, Texas
  187. Bountiful, Utah
  188. Appomattox, Virginia
  189. Burke, Virginia
  190. Forest, Virginia
  191. Suffolk, Virginia
  192. Winchester, Virginia
  193. Winchester, Virginia
  194. Everett, Washington
  195. Everett, Washington
  196. Tacoma, Washington
  197. Eau Claire, Wisconsin
  198. La Crosse, Wisconsin
  199. La Crosse, Wisconsin
  200. Madison, Wisconsin
ALL GENDERS
70 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Determine if Identification of Undiagnosed Atrial Fibrillation in People at Least 70 Years of Age Reduces the Risk of Stroke
Official Title  ICMJE GUARD-AF: reducinG Stroke by Screening for UndiAgnosed atRial Fibrillation in Elderly inDividuals
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Atrial Fibrillation
  • Atrial Flutter
Intervention  ICMJE Other: Zio®XT Monitor
A Zio® XT monitor will be affixed to the participant's chest
Study Arms  ICMJE
  • Zio®XT Monitor Arm
    Intervention: Other: Zio®XT Monitor
  • No Intervention: Usual Care Arm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 11, 2019)
52000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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)

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

Other protocol-defined inclusion/exclusion criteria could apply

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,please email:[email protected]
Contact: First line of the email MUST contain NCT# and Site #.
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04126486
Other Study ID Numbers  ICMJE CV185-749
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP