A Comparison of Magnetic Resonance Imaging in Persons With Heart Failure to Health, Aged Matched Controls (MIND-HF)
20. september 2017 opdateret af: Rebecca Gary, Emory University
A Comparison of Magnetic Resonance Imaging in Persons With Heart Failure to Health, Aged Matched Controls (MIND-HF)
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
30
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Georgia
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Atlanta, Georgia, Forenede Stater, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, Forenede Stater, 30322
- The Emory Clinic
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Atlanta, Georgia, Forenede Stater, 30342
- Emory St. Joseph's Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Men and women with heart failure and men and women without heart failure to serve as healthy age-matched controls.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Participants with Heart Failure
Participants with heart failure will complete neurocognitive tests and undergo magnetic resonance imaging (MRI).
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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).
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Healthy Controls
Healthy controls will complete neurocognitive tests and undergo magnetic resonance imaging (MRI).
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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).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Structural White Matter
Tidsramme: Visit 1 (Up to 2 hours)
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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.
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Visit 1 (Up to 2 hours)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Functional Connectivity
Tidsramme: Visit 1 (Up to 2 hours)
|
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.
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Visit 1 (Up to 2 hours)
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Global Cerebral Blood Flow (CBF)
Tidsramme: Visit 1 (Up to 2 hours)
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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.
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Visit 1 (Up to 2 hours)
|
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Regional Cerebral Blood Flow (CBF)
Tidsramme: Visit 1 (Up to 2 hours)
|
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.
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Visit 1 (Up to 2 hours)
|
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Structural Grey Matter
Tidsramme: Visit 1 (Up to 2 hours)
|
Voxel-based morphometry (VBM) of T1-weighted (T1w) high-resolution magnetic resonance imaging MRI anatomics will be used to measure brain structural white matter.
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Visit 1 (Up to 2 hours)
|
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Cognitive Function assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Tidsramme: Visit 2 (Up to 2 hours)
|
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.
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Visit 2 (Up to 2 hours)
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Cognitive Function assessed by the Controlled Oral Word Association (COWA) Test
Tidsramme: Visit 2 (Up to 2 hours)
|
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.
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Visit 2 (Up to 2 hours)
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Cognitive Function assessed by the Color Trails Test
Tidsramme: Visit 2 (Up to 2 hours)
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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.
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Visit 2 (Up to 2 hours)
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Cognitive Function assessed by the Wechsler Adult Intelligence Scale-III (WAIS-III) Digit Span Test
Tidsramme: Visit 2 (Up to 2 hours)
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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.
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Visit 2 (Up to 2 hours)
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Cognitive Function assessed by the Wechsler Adult Intelligence Scale-III (WAIS-III) Letter Number Sequence Test
Tidsramme: Visit 2 (Up to 2 hours)
|
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
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Visit 2 (Up to 2 hours)
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Cognitive Function assessed by the Stroop Test
Tidsramme: Visit 2 (Up to 2 hours)
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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
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Visit 2 (Up to 2 hours)
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Cognitive Function assessed by the California Computerized Assessment Package (CALCAP)
Tidsramme: Visit 2 (Up to 2 hours)
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The California Computerized Assessment Package assesses reaction times, speed of information processing, rapid visual scanning, form discrimination, brief memory and divided attention.
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Visit 2 (Up to 2 hours)
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Self-Management assessed by the Self-care Index Heart Failure (SCHFI)
Tidsramme: Visit 2 (Up to 2 hours)
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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.
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Visit 2 (Up to 2 hours)
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Peak oxygen consumption assessed by the Modified Balke Test
Tidsramme: Visit 2 (Up to 2 hours)
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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.
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Visit 2 (Up to 2 hours)
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Quality of Life assessed by the Kansas City Cardiomyopathy Questionnaire
Tidsramme: Visit 2 (Up to 2 hours)
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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.
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Visit 2 (Up to 2 hours)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Rebecca Gary, Emory University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2015
Primær færdiggørelse (Faktiske)
1. juni 2017
Studieafslutning (Faktiske)
1. august 2017
Datoer for studieregistrering
Først indsendt
7. oktober 2015
Først indsendt, der opfyldte QC-kriterier
7. oktober 2015
Først opslået (Skøn)
9. oktober 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. september 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. september 2017
Sidst verificeret
1. september 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00083607
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .