A Comparison of Magnetic Resonance Imaging in Persons With Heart Failure to Health, Aged Matched Controls

Heart Failure Clinical Trial

— MIND-HF  

Official title:

A Comparison of Magnetic Resonance Imaging in Persons With Heart Failure to Health, Aged Matched Controls (MIND-HF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572648
• Other study ID #: IRB00083607
• Status: Completed
• Phase: N/A
• First received: October 7, 2015
• Last updated: September 20, 2017
• Start date: October 2015
• Est. completion date: August 2017

Study information

• Verified date: September 2017
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

Participants with heart failure:

• 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:

Participants with heart failure:

• 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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• 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).

Locations

Country	Name	City	State
United States	Emory St. Joseph's Hospital	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	The Emory Clinic	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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)
Secondary	Global Cerebral Blood Flow (CBF)	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)