A Comparison of Magnetic Resonance Imaging in Persons With Heart Failure to Health, Aged Matched Controls (MIND-HF)
20. September 2017 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
30
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, Vereinigte Staaten, 30322
- The Emory Clinic
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Atlanta, Georgia, Vereinigte Staaten, 30342
- Emory St. Joseph's Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
40 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
Men and women with heart failure and men and women without heart failure to serve as healthy age-matched controls.
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Structural White Matter
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Functional Connectivity
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Rebecca Gary, Emory University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Oktober 2015
Primärer Abschluss (Tatsächlich)
1. Juni 2017
Studienabschluss (Tatsächlich)
1. August 2017
Studienanmeldedaten
Zuerst eingereicht
7. Oktober 2015
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
7. Oktober 2015
Zuerst gepostet (Schätzen)
9. Oktober 2015
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
21. September 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
20. September 2017
Zuletzt verifiziert
1. September 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRB00083607
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