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

20 settembre 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

30

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 40 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Participants with Heart Failure
Participants with heart failure will complete neurocognitive tests and undergo magnetic resonance imaging (MRI).
Altro: 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.

Altro: 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).
Altro: 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.

Altro: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Structural White Matter
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Functional Connectivity
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Emory University

Collaboratori

National Institute of Nursing Research (NINR)

Investigatori

  • Investigatore principale: Rebecca Gary, Emory University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2015

Completamento primario (Effettivo)

1 giugno 2017

Completamento dello studio (Effettivo)

1 agosto 2017

Date di iscrizione allo studio

Primo inviato

7 ottobre 2015

Primo inviato che soddisfa i criteri di controllo qualità

7 ottobre 2015

Primo Inserito (Stima)

9 ottobre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 settembre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 settembre 2017

Ultimo verificato

1 settembre 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRB00083607

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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