- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02572648
A Comparison of Magnetic Resonance Imaging in Persons With Heart Failure to Health, Aged Matched Controls (MIND-HF)
A Comparison of Magnetic Resonance Imaging in Persons With Heart Failure to Health, Aged Matched Controls (MIND-HF)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Georgia
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Atlanta, Georgia, Estados Unidos, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, Estados Unidos, 30322
- The Emory Clinic
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Atlanta, Georgia, Estados Unidos, 30342
- Emory St. Joseph's Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
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).
|
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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Structural White Matter
Periodo de tiempo: 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.
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Visit 1 (Up to 2 hours)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Functional Connectivity
Periodo de tiempo: 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)
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Global Cerebral Blood Flow (CBF)
Periodo de tiempo: 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)
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Regional Cerebral Blood Flow (CBF)
Periodo de tiempo: 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)
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Structural Grey Matter
Periodo de tiempo: 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)
Periodo de tiempo: 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)
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Cognitive Function assessed by the Controlled Oral Word Association (COWA) Test
Periodo de tiempo: 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)
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Cognitive Function assessed by the Color Trails Test
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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
Periodo de tiempo: 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)
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Cognitive Function assessed by the California Computerized Assessment Package (CALCAP)
Periodo de tiempo: 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.
|
Visit 2 (Up to 2 hours)
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Self-Management assessed by the Self-care Index Heart Failure (SCHFI)
Periodo de tiempo: 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.
|
Visit 2 (Up to 2 hours)
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Peak oxygen consumption assessed by the Modified Balke Test
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Rebecca Gary, Emory University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00083607
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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