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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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The purpose of this study is to examine the relation between the structural brain changes associated with heart failure, neurocognitive performance, and how these changes impact self-care behaviors.
The purpose of this study is use neuroimaging techniques to better understand the underlying structural brain changes and physiological mechanisms that guide the thinking and decision making processes required for people with heart failure. The study will compare how the underlying brain structures and circulation are similar to or different in persons with heart failure to healthy, aged matched controls using special neuroimaging procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Heart Failure | Participants with heart failure will complete neurocognitive tests and undergo magnetic resonance imaging (MRI). |
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| Healthy Controls | Healthy controls will complete neurocognitive tests and undergo magnetic resonance imaging (MRI). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain Imaging (Neuroimaging) | Other | Magnetic Resonance Imaging (MR) will be acquired on a research dedicated Siemens 3Tesla TIM TRIO MRI scanner with a 32-channel head coil.The MRI scanning protocol will have scans to measure voxelwise and whole-brain measures of grey matter (GM) volumes through a high resolution T1-weighted (T1W) multi-echo magnetization prepared gradient echo (MEMPRAGE) anatomic scan. Total time in scanner will be approximately 53 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Structural White Matter | Diffusion tensor imaging (DTI) and myelin water imaging (MWI) will be used to compare brain structural white matter between participants with heart failure and healthy controls. This will be obtained via magnetic resonance imaging (MRI) techniques. | Visit 1 (Up to 2 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Connectivity | Functional connectivity that regulates neurocognitive functions will be assessed by blood oxygen level dependent resting state functional MRI (rsFMRI).This will be obtained via magnetic resonance imaging (MRI) techniques. | Visit 1 (Up to 2 hours) |
| Global Cerebral Blood Flow (CBF) |
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Inclusion Criteria:
Participants with heart failure:
Healthy Controls
Exclusion Criteria:
Participants with heart failure:
Healthy Controls
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Men and women with heart failure and men and women without heart failure to serve as healthy age-matched controls.
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Gary | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States | ||
| The Emory Clinic |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D059906 | Neuroimaging |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003943 | Diagnostic Techniques, Neurological |
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| Cognitive Function Assessment | Other | Cognitive function will be assessed using several batteries; the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), the Controlled Oral Word Association Test (COWA), the Color Trails 1 & 2, the WAIS-III Digit Span and Letter Number Sequence test, the Stroop Test, and the California Computerized Assessment Package Reaction Time test (CALCAP). |
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Arterial spin labeling (ASL) based magnetic resonance (MR) perfusion imaging will evaluate global cerebral blood flow (CBF). This will be obtained via magnetic resonance imaging (MRI) techniques. |
| Visit 1 (Up to 2 hours) |
| Regional Cerebral Blood Flow (CBF) | Arterial spin labeling (ASL) based magnetic resonance (MR) perfusion imaging will evaluate regional cerebral blood flow (CBF). This will be obtained via magnetic resonance imaging (MRI) techniques. | Visit 1 (Up to 2 hours) |
| Structural Grey Matter | Voxel-based morphometry (VBM) of T1-weighted (T1w) high-resolution magnetic resonance imaging MRI anatomics will be used to measure brain structural white matter. | Visit 1 (Up to 2 hours) |
| Cognitive Function assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a brief, individually administered test designed to evaluate neuropsychological status of adults, ages 20-89. The 12 subtests measure attention, language, visuospatial/constructional abilities, and immediate and delayed memory. | Visit 2 (Up to 2 hours) |
| Cognitive Function assessed by the Controlled Oral Word Association (COWA) Test | The Controlled Oral Word Association (COWA) Test is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter. The more words produced in the allotted time period the higher the score. | Visit 2 (Up to 2 hours) |
| Cognitive Function assessed by the Color Trails Test | The Color Trails Test measures sustained attention and sequencing. For Part 1, the respondent uses a pencil to rapidly connect circles numbered 1-25 in sequence. For Part 2, the respondent rapidly connects numbered circles in sequence, but alternates between pink and yellow. The length of time to complete each trial is recorded, along with qualitative features of performance indicative of brain dysfunction, such as near-misses, prompts, number sequence errors, and color sequence errors. | Visit 2 (Up to 2 hours) |
| Cognitive Function assessed by the Wechsler Adult Intelligence Scale-III (WAIS-III) Digit Span Test | The Wechsler Adult Intelligence Scale-III (WAIS-III) Digit Span Test measures short-term memory, attention, and concentration. Participants will be asked to repeat 3 - 9 digits forward and 2 - 9 digits backwards. | Visit 2 (Up to 2 hours) |
| Cognitive Function assessed by the Wechsler Adult Intelligence Scale-III (WAIS-III) Letter Number Sequence Test | During the Wechsler Adult Intelligence Scale-III (WAIS-III) Letter Number Sequence Test, participants will be presented with combinations of letters and numbers, (two to nine letter-number combinations). Participants will be asked to repeat each series by, first, repeating the numbers in ascending order, then the letters in alphabetical order. The test measures working memory or the ability to simultaneously recall and organize stimuli of different and similar types | Visit 2 (Up to 2 hours) |
| Cognitive Function assessed by the Stroop Test | The Stroop Test measure a person's selective attention capacity and skills, as well as their processing speed ability.It is used to examine a person's executive processing abilities. The Stroop Test during brain imaging studies is used to investigate regions of the brain that are involved in planning, decision-making, and managing real-world interference | Visit 2 (Up to 2 hours) |
| Cognitive Function assessed by the California Computerized Assessment Package (CALCAP) | The California Computerized Assessment Package assesses reaction times, speed of information processing, rapid visual scanning, form discrimination, brief memory and divided attention. | Visit 2 (Up to 2 hours) |
| Self-Management assessed by the Self-care Index Heart Failure (SCHFI) | The Self-care Index Heart Failure (SCHFI) is a measure designed to assess self-care maintenance, management, and confidence. Participants will be asked to recall feelings of the aforementioned in the last three months. | Visit 2 (Up to 2 hours) |
| Peak oxygen consumption assessed by the Modified Balke Test | Peaked oxygen consumption will be assessed by the Modified Balke Test. Participants will be asked to walk on a slightly inclined treadmill. The amount of oxygen consumed will be measured while walking for up to ten minutes. | Visit 2 (Up to 2 hours) |
| Quality of Life assessed by the Kansas City Cardiomyopathy Questionnaire | The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. | Visit 2 (Up to 2 hours) |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Emory St. Joseph's Hospital | Atlanta | Georgia | 30342 | United States |
| D008919 | Investigative Techniques |