Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
132 participants
OBSERVATIONAL
2017-03-20
2019-09-03
Brief Summary
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Detailed Description
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Patients who have electrocardiographically confirmed atrial fibrillation, are being followed by the Pen Bay Medical Center Anticoagulation Services and are at least 90 years old will be recruited into the study. A matched cohort of patients between the ages of 80 and 89 and another matched cohort of patients between the ages of 70 and 79 will also be recruited into the study for comparison.
Data related to adverse events, concomitant medications, living arrangements, mobility and alcohol use will be collected every 6 months. In addition the CHA2DS2-VASc (score for atrial fibrillation stroke risk), HAS - BLED (major bleeding risk score for patients on anticoagulation), frailty and Mini Cog scores will be recalculated at each visit.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Aged 90 and older
Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin
Patients on warfarin for atrial fibrillation
Aged 80-89
Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin
Patients on warfarin for atrial fibrillation
Aged 70-79
Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
Warfarin
Patients on warfarin for atrial fibrillation
Interventions
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Warfarin
Patients on warfarin for atrial fibrillation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* electrocardiographically confirmed atrial fibrillation
* anticipated regular follow up with patient by Penobscot Bay Medical Center (PBMC) Anticoagulation Services
* Subject or legally authorized representative must be willing to provide informed consent
Exclusion Criteria
70 Years
ALL
No
Sponsors
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Robert Stein
OTHER
Responsible Party
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Robert Stein
Medical Director of Anticoagulation Services
Principal Investigators
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Robert W. Stein, MD
Role: PRINCIPAL_INVESTIGATOR
MaineHealth
Locations
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Penobscot Bay Medical Center
Rockport, Maine, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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PenobscotBMC
Identifier Type: -
Identifier Source: org_study_id
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