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

2017년 9월 20일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (실제)

30

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

40년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Participants with Heart Failure
Participants with heart failure will complete neurocognitive tests and undergo magnetic resonance imaging (MRI).
다른: 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.

다른: 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).
다른: 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.

다른: 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).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Structural White Matter
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Functional Connectivity
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Emory University

협력자

National Institute of Nursing Research (NINR)

수사관

  • 수석 연구원: Rebecca Gary, Emory University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2015년 10월 1일

기본 완료 (실제)

2017년 6월 1일

연구 완료 (실제)

2017년 8월 1일

연구 등록 날짜

최초 제출

2015년 10월 7일

QC 기준을 충족하는 최초 제출

2015년 10월 7일

처음 게시됨 (추정)

2015년 10월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 9월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 9월 20일

마지막으로 확인됨

2017년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • IRB00083607

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