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
Ochsner Medical Center
New Orleans, Louisiana, 70121, 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. New Orleans, Louisiana
  2. Linden, New Jersey
  3. Everett, Washington
  4. Birmingham, Alabama
  5. Guntersville, Alabama
  6. Huntsville, Alabama
  7. Montgomery, Alabama
  8. Kingman, Arizona
  9. Peoria, Arizona
  10. Peoria, Arizona
  11. Phoenix, Arizona
  12. Phoenix, Arizona
  13. Yuma, Arizona
  14. Little Rock, Arkansas
  15. Canoga Park, California
  16. Fremont, California
  17. Fullerton, California
  18. Los Angeles, California
  19. Mission Viejo, California
  20. Oakland, California
  21. Palm Springs, California
  22. Sacramento, California
  23. Sacramento, California
  24. San Francisco, 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 Lauderdale, Florida
  41. Fort Myers, Florida
  42. Hialeah, Florida
  43. Hialeah, Florida
  44. Hialeah, Florida
  45. Jacksonville, Florida
  46. Jacksonville, Florida
  47. Jacksonville, Florida
  48. Lake City, Florida
  49. Miami Beach, Florida
  50. Miami Lakes, Florida
  51. Miami Lakes, Florida
  52. Miami Shores, Florida
  53. Miami, Florida
  54. Miami, Florida
  55. Miami, Florida
  56. Miami, Florida
  57. Miami, Florida
  58. Miami, Florida
  59. Miami, Florida
  60. Miami, Florida
  61. Miami, Florida
  62. Mount Dora, Florida
  63. Oviedo, Florida
  64. Palm Harbor, Florida
  65. Palm Springs, Florida
  66. Sweetwater, Florida
  67. Tampa, Florida
  68. Tampa, Florida
  69. Weston, Florida
  70. Albany, Georgia
  71. Atlanta, Georgia
  72. Columbus, Georgia
  73. Eatonton, Georgia
  74. Fayetteville, Georgia
  75. Rincon, Georgia
  76. Sandy Springs, Georgia
  77. Savannah, Georgia
  78. Woodstock, Georgia
  79. Chicago, Illinois
  80. Evergreen Park, Illinois
  81. Gillespie, Illinois
  82. Wauconda, Illinois
  83. Indianapolis, Indiana
  84. Michigan City, Indiana
  85. Ames, Iowa
  86. Iowa City, Iowa
  87. Leawood, Kansas
  88. Wichita, Kansas
  89. Lexington, Kentucky
  90. Crowley, Louisiana
  91. Eunice, Louisiana
  92. Shreveport, Louisiana
  93. Zachary, Louisiana
  94. Annapolis, Maryland
  95. Baltimore, Maryland
  96. Elkridge, Maryland
  97. Hyattsville, Maryland
  98. Rockville, Maryland
  99. Boston, Massachusetts
  100. Boston, Massachusetts
  101. Boston, Massachusetts
  102. Haverhill, Massachusetts
  103. New Bedford, Massachusetts
  104. Worcester, Massachusetts
  105. Caro, Michigan
  106. Detroit, Michigan
  107. Sterling Heights, Michigan
  108. Troy, Michigan
  109. Minneapolis, Minnesota
  110. Amory, Mississippi
  111. Belzoni, Mississippi
  112. Jackson, Mississippi
  113. Petal, Mississippi
  114. Picayune, Mississippi
  115. Ridgeland, Mississippi
  116. Chesterfield, Missouri
  117. Florissant, Missouri
  118. Saint Louis, Missouri
  119. Norfolk, Nebraska
  120. Henderson, Nevada
  121. Las Vegas, Nevada
  122. Brooklyn, New York
  123. Cooperstown, New York
  124. East Syracuse, New York
  125. Endwell, New York
  126. North Massapequa, New York
  127. Black Mountain, North Carolina
  128. Burlington, North Carolina
  129. Cary, North Carolina
  130. Charlotte, North Carolina
  131. Charlotte, North Carolina
  132. Charlotte, North Carolina
  133. Durham, North Carolina
  134. Fayetteville, North Carolina
  135. Franklinton, North Carolina
  136. Greensboro, North Carolina
  137. Hickory, North Carolina
  138. Matthews, North Carolina
  139. Raleigh, North Carolina
  140. Raleigh, North Carolina
  141. Rocky Mount, North Carolina
  142. Salisbury, North Carolina
  143. Statesville, North Carolina
  144. Statesville, North Carolina
  145. Wilmington, North Carolina
  146. Winston-Salem, North Carolina
  147. Winston-Salem, North Carolina
  148. Cincinnati, Ohio
  149. Cincinnati, Ohio
  150. Cincinnati, Ohio
  151. Cleveland, Ohio
  152. Columbus, Ohio
  153. Dayton, Ohio
  154. Dayton, Ohio
  155. Norman, Oklahoma
  156. Danville, Pennsylvania
  157. Philadelphia, Pennsylvania
  158. Pittsburgh, Pennsylvania
  159. Pittsburgh, Pennsylvania
  160. Pittsburgh, Pennsylvania
  161. Uniontown, Pennsylvania
  162. Uniontown, Pennsylvania
  163. East Providence, Rhode Island
  164. Bristol, Tennessee
  165. Knoxville, Tennessee
  166. Morristown, Tennessee
  167. Nashville, Tennessee
  168. Allen, Texas
  169. Austin, Texas
  170. Austin, Texas
  171. Dallas, Texas
  172. Dallas, Texas
  173. Denton, Texas
  174. Edinburg, Texas
  175. Friendswood, Texas
  176. Georgetown, Texas
  177. Houston, Texas
  178. Houston, Texas
  179. Hurst, Texas
  180. Laredo, Texas
  181. Mesquite, Texas
  182. Pearland, Texas
  183. Pflugerville, Texas
  184. Pharr, Texas
  185. Plano, Texas
  186. Plano, Texas
  187. San Antonio, Texas
  188. San Antonio, Texas
  189. San Marcos, Texas
  190. Sugar Land, Texas
  191. Sugar Land, Texas
  192. Temple, Texas
  193. The Woodlands, Texas
  194. The Woodlands, Texas
  195. Tyler, Texas
  196. Bountiful, Utah
  197. Appomattox, Virginia
  198. Burke, Virginia
  199. Forest, Virginia
  200. Suffolk, Virginia
  201. Winchester, Virginia
  202. Winchester, Virginia
  203. Everett, Washington
  204. Tacoma, Washington
  205. Eau Claire, Wisconsin
  206. La Crosse, Wisconsin
  207. La Crosse, Wisconsin
  208. 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 November 2020

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