A Comparison of Magnetic Resonance Imaging in Persons With Heart Failure to Health, Aged Matched Controls
MIND-HF
1 other identifier
observational
30
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2015
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 7, 2015
CompletedFirst Posted
Study publicly available on registry
October 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedSeptember 21, 2017
September 1, 2017
1.7 years
October 7, 2015
September 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (14)
Functional Connectivity
Visit 1 (Up to 2 hours)
Global Cerebral Blood Flow (CBF)
Visit 1 (Up to 2 hours)
Regional Cerebral Blood Flow (CBF)
Visit 1 (Up to 2 hours)
Structural Grey Matter
Visit 1 (Up to 2 hours)
Cognitive Function assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Visit 2 (Up to 2 hours)
- +9 more secondary outcomes
Study Arms (2)
Participants with Heart Failure
Participants with heart failure will complete neurocognitive tests and undergo magnetic resonance imaging (MRI).
Healthy Controls
Healthy controls will complete neurocognitive tests and undergo magnetic resonance imaging (MRI).
Interventions
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 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
Men and women with heart failure and men and women without heart failure to serve as healthy age-matched controls.
You may qualify if:
- 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
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- National Institute of Nursing Research (NINR)collaborator
Study Sites (3)
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
Emory St. Joseph's Hospital
Atlanta, Georgia, 30342, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca Gary
Emory University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 7, 2015
First Posted
October 9, 2015
Study Start
October 1, 2015
Primary Completion
June 1, 2017
Study Completion
August 1, 2017
Last Updated
September 21, 2017
Record last verified: 2017-09