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)

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 informed consent and conduct of baseline procedures, subjects will be
required to return to clinic at 6, 12, 18 and 24 months after enrollment. Cognitive testing
will be performed at baseline and repeated at 24 months. As much as possible, the study
follow-up visits will be scheduled at the same time as the patients' regular visits for
clinical care.

Six questionnaires will be administered at the baseline visit and repeated at the 24-month
visit. At the time of cognitive assessment, the following will be completed, if not already
performed as part of usual standard of care: complete blood count, protime/INR, basic
metabolic profile, review of cardiac medications, and review of adverse events and
hospitalizations. Additional serum tests will be performed on all subjects at enrollment and
at the 24-month visit. Biomarkers will be drawn at specific intervals (baseline, 6, 12, 18,
and 24 months) then on an as needed basis (within 7 days) when treatments for atrial
fibrillation that may increase brain injury risk occur.

Inclusion Criteria:

1. Male or female 65 to ≤ 95 years of age

2. Ability to understand and sign a written informed consent form, which must be obtained
prior to initiation of any study procedures

3. AF documented by electrocardiogram, ambulatory event monitor, telemetry, or medical
records within 12 months of enrollment

4. Ability to complete a mini-mental status evaluation

5. Ability to independently comprehend and complete a quality of life and dementia
questionnaires

6. Willing and able to comply with the follow-up visits, tests, and schedule of
evaluations

Exclusion Criteria:

1. Have a history of any form of dementia

2. Have a life expectancy less than 24 months

3. Participation in any other clinical trials involving investigational or marketed
products within 30 days prior to entry in the study

4. 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

5. The Principal Investigator and/or Sub-Investigator(s) determine(s) that the subject is
not eligible for participation in this research study