ClinicalTrials.gov
ClinicalTrials.gov Menu

Screening for Atrial Fibrillation (AF)-Potential Patients to Increase AF Detection Rate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03313167
Recruitment Status : Recruiting
First Posted : October 18, 2017
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
To assess the prevalence of all (prevalent and paroxysmal) undiagnosed atrial fibrillation (AF) in a Japanese population with a moderate-to-high risk of stroke

Condition or disease Intervention/treatment
Atrial Fibrillation Other: Non-interventional

Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Systematic Screening for Atrial Fibrillation-potential Patients to Increase AF Detection Rate (SCAN-AF)
Actual Study Start Date : September 29, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Atrial Fibrillation-potential Patients
individuals 65 years of age or older with moderate-to-high risk of stroke
Other: Non-interventional
Non-interventional




Primary Outcome Measures :
  1. number of subjects screened with AF identified at Index Visit [ Time Frame: Up to 4 weeks ]
  2. number of subjects screened with AF not identified at Index Visit [ Time Frame: Up to 4 weeks from Index Visit ]
    number of subjects screened who have AF not identified at their Index Visit but subsequently found to have AF confirmed by 12-lead Electrocardiogram (ECG) during the extended monitoring period


Secondary Outcome Measures :
  1. number of subjects with ECG-confirmed AF detected by the Omron BP device [ Time Frame: Day 1 to Day 14 ]
    number of subjects with ECG-confirmed AF detected by the Omron blood pressure (BP) device during the extended monitoring period

  2. number of subjects with ECG-confirmed AF detected by MB or HCG-801 [ Time Frame: Day 14 to Day 28 ]
    number of subjects with ECG-confirmed AF detected by MyBeat (MB) or Omron HeartScan 801 (HCG-801) during the extended monitoring period

  3. number of subjects with AF identified at Index Visit who are prescribed guideline recommended anticoagulation therapy [ Time Frame: 24 week follow up period ]
  4. number of subjects with AF identified at their Index Visit who are prescribed guideline recommended anticoagulation therapy and still on the prescribed anticoagulation therapy at the end of the 24-week follow-up period [ Time Frame: At week 24 ]
  5. number of subjects with Paroxysmal atrial fibrillation (PAF) identified during the extended monitoring period who are prescribed guideline-recommended anticoagulation therapy [ Time Frame: Day 1 to Day 28 ]
  6. number of subjects with PAF identified during the extended monitoring period who are prescribed guideline-recommended anticoagulation therapy and still on the prescribed anticoagulation therapy at the end of the 24-week follow-up [ Time Frame: At week 24 ]
  7. number of subjects with AF identified at the Index Visit who had an ischemic stroke during the 24-week follow-up period [ Time Frame: Index Visit up to week 24 ]
  8. number of subjects with PAF identified during the extended monitoring period who had an ischemic stroke during the 24-week follow-up period [ Time Frame: Day 1 up to week 24 ]
  9. number of subjects with AF identified at the Index Visit who bled during the 24-week follow-up period [ Time Frame: Index Visit up to week 24 ]
  10. number of subjects with PAF identified during the extended monitoring period who bled during the 24-week follow-up period [ Time Frame: Day 1 up to week 24 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Japanese population with a moderate-to high risk of stroke
Criteria

Inclusion Criteria:

  • Age ≥ 65 and one or more of the following: hypertension, prior stroke or transient ischemic attack, congestive heart failure, diabetes mellitus, and/or vascular disease

Exclusion Criteria:

  • Age < 65 years, individuals with AF or a history of AF, or individuals taking anti-arrhythmic drugs

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313167


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
Japan
Local Institution Recruiting
Itabashi-ku, Tokyo, Japan, 173-0003
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03313167     History of Changes
Other Study ID Numbers: CV185-595
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes