このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

2017年9月20日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

観察的

入学 (実際)

30

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Georgia
      • Atlanta、Georgia、アメリカ、30308
        • Emory University Hospital Midtown
      • Atlanta、Georgia、アメリカ、30322
        • The Emory Clinic
      • Atlanta、Georgia、アメリカ、30342
        • Emory St. Joseph's Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

40年～75年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Participants with Heart Failure
Participants with heart failure will complete neurocognitive tests and undergo magnetic resonance imaging (MRI).
他の：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.

他の：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).
他の：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.

他の：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).

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Structural White Matter
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Functional Connectivity
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Emory University

協力者

National Institute of Nursing Research (NINR)

捜査官

  • 主任研究者：Rebecca Gary、Emory University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2015年10月1日

一次修了 (実際)

2017年6月1日

研究の完了 (実際)

2017年8月1日

試験登録日

最初に提出

2015年10月7日

QC基準を満たした最初の提出物

2015年10月7日

最初の投稿 (見積もり)

2015年10月9日

学習記録の更新

投稿された最後の更新 (実際)

2017年9月21日

QC基準を満たした最後の更新が送信されました

2017年9月20日

最終確認日

2017年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • IRB00083607

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

心不全の臨床試験

Brain Imaging (Neuroimaging)の臨床試験

類似の治験を検索

スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Kyrgyzstan

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

3
購読する