Cognitive ChangeConcussion AFNCT03875131
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)
An observational study of Cognitive Change, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Biomarkers of Dementia and Cognitive Decline
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2017to 24 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Moderate- to high-risk atrial fibrillation patients that undergo standard of care atrial fibrillation management at Intermountain Medical Center.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cognitive Change
- Being tested
- Biomarkers of Dementia and Cognitive Decline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarkers of Dementia and Cognitive DeclineOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start15 Jul 2017
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jared Bunch, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875131
- Sponsor's protocol ID
- 1050545
- Acronym
- Concussion AF
- Status last verified
- May 2024
- First submitted
- 25 Jan 2019
- Last updated
- 24 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03875131
- Acronym / sponsor ID
- Concussion AF / 1050545
- Conditions
- Cognitive Change
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Moderate- to high-risk atrial fibrillation patients that undergo standard of care atrial fibrillation management at Intermountain Medical Center.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarkers of Dementia and Cognitive DeclineBiomarkers 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 | Other | – |
Primary outcome
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.
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.
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.
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.
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.
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.
6 secondary outcomes
Moderate change in cognitive decline based on Mini-Mental Status Examination
Time frame: 24 months
Moderate change in cognitive decline based on Hachinski Ischemic Scale
Time frame: 24 months
Moderate change in cognitive decline based on Cognitive Subscale of Alzheimer's Disease Assessment Scale
Time frame: 24 months
Moderate change in cognitive decline based on Disability Assessment for Dementia
Time frame: 24 months
Moderate change in cognitive decline based on Minnesota Living with Heart Failure Scale
Time frame: 24 months
Moderate change in cognitive decline based on Anti-Clot Treatment Scale (ACTS) Quality of Life Survey
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jared Bunch, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Change, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident dementia based on the Mini-Mental Status Examination (time frame: 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.