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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 that undergo standard of care atrial fibrillation management.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomarkers of Dementia and Cognitive Decline | Other | Biomarkers will be obtained at baseline, 6, 12, 18, and 24 months. The six questionnaires listed below will be administered at the baseline visit, and repeated at the 24-month visit to evaluate cognitive decline.
|
| Measure | Description | Time Frame |
|---|---|---|
| Incident dementia based on the Mini-Mental Status Examination | For cognitive assessment, the Mini-Mental Status Examination will be administered at the baseline visit and repeated at the 24-month visits. More information can be obtained at http://www.dhs.state.mn.us/main/groups/county\_access/documents/pub/dhs16\_159601.pdf. | 24 months |
| Incident dementia based on the Hachinski Ischemic Scale | For cognitive assessment, the Hachinski Ischemic Scale will be administered at the baseline visit and repeated at the 24-month visits. More information can be obtained at http://www.strokecenter.org/wp-content/uploads/2011/08/hachinski.pdf. | 24 months |
| Incident dementia based on the Cognitive Subscale of Alzheimer's Disease Assessment Scale | For cognitive assessment, the Cognitive Subscale of Alzheimer's Disease Assessment Scale will be administered at the baseline visit and repeated at the 24-month visits. More information can be obtained at http://www.adcs.org/Industry/instruments.aspx. | 24 months |
| Incident dementia based on the Disability Assessment for Dementia | For cognitive assessment, the Disability Assessment for Dementia will be administered at the baseline visit and repeated at the 24-month visits. More information can be obtained at http://www.statisticssolutions.com/disability-assessment-for-dementia. | 24 months |
| Incident dementia based on the Minnesota Living with Heart Failure Scale | For cognitive assessment, the Minnesota Living with Heart Failure Scale will be administered at the baseline visit and repeated at the 24-month visits. More information can be obtained at http://www.queri.research.va.gov/chf/products/hf\_toolkit/Minnesota-HF-Questionnaire\_Rector.pdf. |
| Measure | Description | Time Frame |
|---|---|---|
| Moderate change in cognitive decline based on Mini-Mental Status Examination | For cognitive assessment, the Mini-Mental Status Examination will be administered at the baseline visit and repeated at the 24-month visits. More information can be obtained at http://www.dhs.state.mn.us/main/groups/county\_access/documents/pub/dhs16\_159601.pdf. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Moderate- to high-risk atrial fibrillation patients that undergo standard of care atrial fibrillation management at Intermountain Medical Center.
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| Name | Affiliation | Role |
|---|---|---|
| Jared Bunch, MD | Intermountain Health Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Medical Center | Murray | Utah | 84143 | United States |
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At each visit a blood sample of 16 mL will be collected for standard blood tests at enrollment, 6,12, 18, and 24 months. Additionally, blood samples will be collected (12 mL) and tested for biomarkers at the time of enrollment, follow-up visits at 6, 12, 18 and 24 months after enrollment. The research staff will keep a portion of the blood that can be used for a future study and it will be maintained in the Intermountain biological specimen repository. Biological samples may be used in current and future research tests multiple times, or until the sample is consumed.
| 24 months |
| Incident dementia based on the Anti-Clot Treatment Scale (ACTS) Quality of Life Survey | For cognitive assessment, the Anti-Clot Treatment Scale (ACTS) Quality of Life Survey will be administered at the baseline visit and repeated at the 24-month visits. More information can be obtained at http://hqlo.biomedcentral.com/articles/10.1186/1477-7525-10-120. | 24 months |
| Moderate change in cognitive decline based on Hachinski Ischemic Scale | For cognitive assessment, the Hachinski Ischemic Scale will be administered at the baseline visit and repeated at the 24-month visits. More information can be obtained at http://www.strokecenter.org/wp-content/uploads/2011/08/hachinski.pdf. | 24 months |
| Moderate change in cognitive decline based on Cognitive Subscale of Alzheimer's Disease Assessment Scale | For cognitive assessment, the Cognitive Subscale of Alzheimer's Disease Assessment Scale will be administered at the baseline visit and repeated at the 24-month visits. More information can be obtained at http://www.adcs.org/Industry/instruments.aspx. | 24 months |
| Moderate change in cognitive decline based on Disability Assessment for Dementia | For cognitive assessment, the Disability Assessment for Dementia will be administered at the baseline visit and repeated at the 24-month visits. More information can be obtained at http://www.statisticssolutions.com/disability-assessment-for-dementia. | 24 months |
| Moderate change in cognitive decline based on Minnesota Living with Heart Failure Scale | For cognitive assessment, the Minnesota Living with Heart Failure Scale will be administered at the baseline visit and repeated at the 24-month visits. More information can be obtained at http://www.queri.research.va.gov/chf/products/hf\_toolkit/Minnesota-HF-Questionnaire\_Rector.pdf. | 24 months |
| Moderate change in cognitive decline based on Anti-Clot Treatment Scale (ACTS) Quality of Life Survey | For cognitive assessment, the Anti-Clot Treatment Scale (ACTS) Quality of Life Survey will be administered at the baseline visit and repeated at the 24-month visits. More information can be obtained at http://hqlo.biomedcentral.com/articles/10.1186/1477-7525-10-120. | 24 months |