Status:
COMPLETED
Definition, Quantification, and Utility of Biomarkers of Repetitive Brain Injury in Predicting Concussion and Other Long-Term Injury Risks in Patients With Atrial Fibrillation (Concussion AF)
Lead Sponsor:
Intermountain Health Care, Inc.
Conditions:
Cognitive Change
Eligibility:
All Genders
65-95 years
Brief Summary
This is a prospective clinical study designed to evaluate biomarkers of brain injury and dementia incidence and moderate cognitive decline rates in moderate- to high-risk atrial fibrillation patients ...
Detailed Description
A written informed consent will be obtained from atrial fibrillation patients seen at Intermountain Medical Center who meet the study eligibility criteria. Following the baseline visit for obtaining i...
Eligibility Criteria
Inclusion
- Male or female 65 to ≤ 95 years of age
- Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures
- AF documented by electrocardiogram, ambulatory event monitor, telemetry, or medical records within 12 months of enrollment
- Ability to complete a mini-mental status evaluation
- Ability to independently comprehend and complete a quality of life and dementia questionnaires
- Willing and able to comply with the follow-up visits, tests, and schedule of evaluations
Exclusion
- Have a history of any form of dementia
- Have a life expectancy less than 24 months
- Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study
- Other conditions that in the opinion of the Principal Investigator and/or Sub-Investigator(s) may increase risk to the subject and/or compromise the quality of the clinical trial
- The Principal Investigator and/or Sub-Investigator(s) determine(s) that the subject is not eligible for participation in this research study
Key Trial Info
Start Date :
July 15 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 24 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03875131
Start Date
July 15 2017
End Date
October 24 2022
Last Update
May 24 2024
Active Locations (1)
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1
Intermountain Medical Center
Murray, Utah, United States, 84143