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

20 września 2017 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Obserwacyjny

Zapisy (Rzeczywisty)

30

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Georgia
      • Atlanta, Georgia, Stany Zjednoczone, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, Stany Zjednoczone, 30322
        • The Emory Clinic
      • Atlanta, Georgia, Stany Zjednoczone, 30342
        • Emory St. Joseph's Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

40 lat do 75 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Men and women with heart failure and men and women without heart failure to serve as healthy age-matched controls.

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Participants with Heart Failure
Participants with heart failure will complete neurocognitive tests and undergo magnetic resonance imaging (MRI).
Inny: 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.

Inny: 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).
Inny: 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.

Inny: 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).

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Structural White Matter
Ramy czasowe: Visit 1 (Up to 2 hours)
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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Functional Connectivity
Ramy czasowe: 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.
Visit 1 (Up to 2 hours)
Global Cerebral Blood Flow (CBF)
Ramy czasowe: Visit 1 (Up to 2 hours)
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)
Regional Cerebral Blood Flow (CBF)
Ramy czasowe: 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.
Visit 1 (Up to 2 hours)
Structural Grey Matter
Ramy czasowe: 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.
Visit 1 (Up to 2 hours)
Cognitive Function assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Ramy czasowe: 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.
Visit 2 (Up to 2 hours)
Cognitive Function assessed by the Controlled Oral Word Association (COWA) Test
Ramy czasowe: 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.
Visit 2 (Up to 2 hours)
Cognitive Function assessed by the Color Trails Test
Ramy czasowe: Visit 2 (Up to 2 hours)
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)
Cognitive Function assessed by the Wechsler Adult Intelligence Scale-III (WAIS-III) Digit Span Test
Ramy czasowe: Visit 2 (Up to 2 hours)
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)
Cognitive Function assessed by the Wechsler Adult Intelligence Scale-III (WAIS-III) Letter Number Sequence Test
Ramy czasowe: 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
Visit 2 (Up to 2 hours)
Cognitive Function assessed by the Stroop Test
Ramy czasowe: Visit 2 (Up to 2 hours)
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)
Cognitive Function assessed by the California Computerized Assessment Package (CALCAP)
Ramy czasowe: Visit 2 (Up to 2 hours)
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)
Self-Management assessed by the Self-care Index Heart Failure (SCHFI)
Ramy czasowe: Visit 2 (Up to 2 hours)
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)
Peak oxygen consumption assessed by the Modified Balke Test
Ramy czasowe: Visit 2 (Up to 2 hours)
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)
Quality of Life assessed by the Kansas City Cardiomyopathy Questionnaire
Ramy czasowe: Visit 2 (Up to 2 hours)
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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Emory University

Współpracownicy

National Institute of Nursing Research (NINR)

Śledczy

  • Główny śledczy: Rebecca Gary, Emory University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 października 2015

Zakończenie podstawowe (Rzeczywisty)

1 czerwca 2017

Ukończenie studiów (Rzeczywisty)

1 sierpnia 2017

Daty rejestracji na studia

Pierwszy przesłany

7 października 2015

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 października 2015

Pierwszy wysłany (Oszacować)

9 października 2015

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

21 września 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

20 września 2017

Ostatnia weryfikacja

1 września 2017

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IRB00083607

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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