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)

NCT03875131 | Completed

• 1 other identifier: 1050545
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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 that undergo standard of care atrial fibrillation management.

Conditions

Cognitive Change

Outcome Measures

Primary Outcomes (6)

• 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.

  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

Secondary Outcomes (6)

• Moderate change in cognitive decline based on Mini-Mental Status Examination

  24 months

• Moderate change in cognitive decline based on Hachinski Ischemic Scale

  24 months

• Moderate change in cognitive decline based on Cognitive Subscale of Alzheimer's Disease Assessment Scale

  24 months

• Moderate change in cognitive decline based on Disability Assessment for Dementia

  24 months

• Moderate change in cognitive decline based on Minnesota Living with Heart Failure Scale

  24 months

Interventions

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. * Mini-Mental Status Evaluation * Hachinski Ischemic Scale * Cognitive Subscale of Alzheimer's Disease Assessment Scale * Disability Assessment for dementia * Quality of life improvement as assessed by: * Minnesota Living with Heart Failure Scale * Anti-Clot Treatment Scale (ACTS) Quality of Life Survey

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Moderate- to high-risk atrial fibrillation patients that undergo standard of care atrial fibrillation management at Intermountain Medical Center.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84143, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

Study Officials

• Jared Bunch, MD

  Intermountain Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: March 14, 2019
• Study Start: July 15, 2017
• Primary Completion: October 24, 2022
• Study Completion: October 24, 2022
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)