A Comparison of Magnetic Resonance Imaging in Persons With Heart Failure to Health, Aged Matched Controls
NCT ID: NCT02572648
Last Updated: 2017-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2015-10-31
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Participants with Heart Failure
Participants with heart failure will complete neurocognitive tests and undergo magnetic resonance imaging (MRI).
Brain Imaging (Neuroimaging)
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.
Cognitive Function Assessment
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).
Healthy Controls
Healthy controls will complete neurocognitive tests and undergo magnetic resonance imaging (MRI).
Brain Imaging (Neuroimaging)
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.
Cognitive Function Assessment
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).
Interventions
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Brain Imaging (Neuroimaging)
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.
Cognitive Function Assessment
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).
Eligibility Criteria
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Inclusion Criteria
* Speak and understand English
* Live independently within a 60 mile radius of Atlanta
* Montreal Cognitive Assessment (MOCA) score of less than or equal to 24
* Documented medical diagnosis of New York Heart Association (NYHA) class II or III systolic
* Left ventricular ejection fraction (LVEF) greater than or equal to 10% that is documented within the last year by echocardiogram, cardiac catheterization ventriculography, or radionuclide ventriculography
* Receiving medication therapy for heart failure (HF) according to American College of Cardiology (ACC) American Heart recommendation guidelines for at least 8 weeks prior to study enrollment
Healthy Controls
* Speak and understand English
* Live independently within a 60 mile radius of Atlanta
Exclusion Criteria
* New York Heart Association (NYHA) class I or IV
* Change in heart failure (HF) therapy within 6 months
* Worsening of heart failure (HF) symptoms within last 5 days
* Unstable angina
* Renal insufficiency (serum creatinine greater than 3.o mg/dL)
* Hospitalized within the last 30-days
* Diagnosed with any neurological disorder that may interfere with cognitive function
* Beck Depression Inventory II (BDI-II) score greater than 25
* Claustrophobia
* Implanted devices such as internal cardiac defibrillator or pacemaker
* Carrying non-removable objects
* Stents
* Body weight more than 120 kg
Healthy Controls
* Taking prescription medications
* Cardiovascular disease;
* Cerebrovascular disease
* Neurological disease
* Respiratory disease
* Claustrophobia
* Any implanted metal objects not considered safe or appropriate for the MRI environment.
40 Years
75 Years
ALL
Yes
Sponsors
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National Institute of Nursing Research (NINR)
NIH
Emory University
OTHER
Responsible Party
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Rebecca Gary
Associate Professor
Principal Investigators
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Rebecca Gary
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University Hospital Midtown
Atlanta, Georgia, United States
The Emory Clinic
Atlanta, Georgia, United States
Emory St. Joseph's Hospital
Atlanta, Georgia, United States
Countries
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Other Identifiers
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IRB00083607
Identifier Type: -
Identifier Source: org_study_id