A Comparison of Magnetic Resonance Imaging in Persons With Heart Failure to Health, Aged Matched Controls (MIND-HF)
20. září 2017 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Pozorovací
Zápis (Aktuální)
30
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Georgia
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Atlanta, Georgia, Spojené státy, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, Spojené státy, 30322
- The Emory Clinic
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Atlanta, Georgia, Spojené státy, 30342
- Emory St. Joseph's Hospital
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
40 let až 75 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
Men and women with heart failure and men and women without heart failure to serve as healthy age-matched controls.
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Structural White Matter
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Functional Connectivity
Časové okno: Visit 1 (Up to 2 hours)
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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)
Časové okno: 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)
Časové okno: Visit 1 (Up to 2 hours)
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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
Časové okno: Visit 1 (Up to 2 hours)
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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)
Časové okno: Visit 2 (Up to 2 hours)
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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
Časové okno: Visit 2 (Up to 2 hours)
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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
Časové okno: 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
Časové okno: 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
Časové okno: Visit 2 (Up to 2 hours)
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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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Rebecca Gary, Emory University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. října 2015
Primární dokončení (Aktuální)
1. června 2017
Dokončení studie (Aktuální)
1. srpna 2017
Termíny zápisu do studia
První předloženo
7. října 2015
První předloženo, které splnilo kritéria kontroly kvality
7. října 2015
První zveřejněno (Odhad)
9. října 2015
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
21. září 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
20. září 2017
Naposledy ověřeno
1. září 2017
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IRB00083607
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .