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) (Concussion AF)

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Change
• Intervention / Treatment: Other: Biomarkers of Dementia and Cognitive Decline

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 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.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84143
      • Intermountain Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 95 years (Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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 Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Investigators: Principal Investigator: Jared Bunch, MD, Intermountain Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2017
• Primary Completion (Actual): October 24, 2022
• Study Completion (Actual): October 24, 2022

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Arrhythmias, Cardiac; Brain Injuries; Atrial Fibrillation
• Other Study ID Numbers: 1050545

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No