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Completed

NCT Number: NCT03875131

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)

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.

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Key information

Conditions

Cognitive Change

Age range

65 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Intermountain Medical Center

Murray, Utah, 84143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Incident dementia based on the Mini-Mental Status Examination

    Time frame: 24 months

    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.

  2. Incident dementia based on the Hachinski Ischemic Scale

    Time frame: 24 months

    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.

  3. Incident dementia based on the Cognitive Subscale of Alzheimer's Disease Assessment Scale

    Time frame: 24 months

    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.

  4. Incident dementia based on the Disability Assessment for Dementia

    Time frame: 24 months

    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.

  5. Incident dementia based on the Minnesota Living with Heart Failure Scale

    Time frame: 24 months

    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.

  6. Incident dementia based on the Anti-Clot Treatment Scale (ACTS) Quality of Life Survey

    Time frame: 24 months

    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.

Secondary outcomes

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

    Time frame: 24 months

    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.

  2. Moderate change in cognitive decline based on Hachinski Ischemic Scale

    Time frame: 24 months

    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.

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

    Time frame: 24 months

    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.

  4. Moderate change in cognitive decline based on Disability Assessment for Dementia

    Time frame: 24 months

    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.

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

    Time frame: 24 months

    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.

  6. Moderate change in cognitive decline based on Anti-Clot Treatment Scale (ACTS) Quality of Life Survey

    Time frame: 24 months

    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.

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Registry information

Acronym: Concussion AF

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Mar 14, 2019
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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