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临床试验/NCT01043315
NCT01043315已完成不适用

Cognitive Function in Adults With Cardiac Disease

University Hospitals Cleveland Medical Center1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
Cognitive Function as measured by Modified Mini Mental Status (3MS) Examination

研究概览

简要总结

The purpose of this study is to identify cardiac patients' degree of unappreciated mild impairment in cognitive function patterns of cognitive function, and influencing factors related to cognitive functioning during hospitalization. The results from the study will contribute to tailoring the delivery of patient education to optimize patient understanding of information in future clinical practice.

It is hypothesized that the study will demonstrate the following:

  1. The degree of cognitive function for patients hospitalized in a CICU will be below the scores for normal functioning adults.
  2. Patients with acute cardiovascular conditions will score differently in cognitive functioning at various times throughout their hospitalization.
  3. Relationships between cognitive function and following variables:
  • Patients with greater sleep deprivation or fatigue will exhibit lower cognitive functioning.
  • Patients with greater hunger will exhibit lower cognitive functioning.
  • Patients who are experiencing greater anxiety will exhibit lower cognitive functioning.
  • Patients who are experiencing depression will exhibit lower cognitive functioning.
  • Patients who have undergone or will undergo shortly treatment or procedures will exhibit lower cognitive functioning.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admission to the Cardiac Intensive Care Unite for acute cardiological issues during time of enrollment.
  • Patients with NYHA class I, II, III, and IV.
  • 18 years or older and must be awake and conversant at time of enrollment.

排除标准

  • History of neurological disorder or injury (e.g., Alzheimer's Disease, dementia, stroke, seizures).
  • Moderate or severe head injury (defined as > 24 hours loss of consciousness)
  • Past or current history of severe psychiatric illness. Specifically, psychotic disorders (e.g., schizophrenia) and bipolar disorder. Potential participants will not be excluded on the basis of managed depression or anxiety disorder. These conditions are common in cardiac patients and their exclusion may limit the generalizability of findings.
  • 5 years past or current history of alcohol or drug abuse (defined by DSM-IV criteria).
  • History of learning disorder or developmental disability (defined by DSM-IV criteria).
  • Renal failure requiring dialysis.
  • History of sleep apnea (defined through previous sleep studies).
  • Severely ill individuals, including those who are sedated, on a ventilator, exhibiting acute hemodynamic changes, and/or those deemed inappropriate by patient's physician to participate in study.

结局指标

主要结局

Cognitive Function as measured by Modified Mini Mental Status (3MS) Examination

时间窗: Up to 3 hours prior to discharge

Cognitive Function as measured by Rey Auditory Verbal Learning

时间窗: Up to 3 hours prior to discharge

Cognitive Function as measured by Trails testing

时间窗: Up to 3 hours prior to discharge

Cognitive Function as measured by Digit Span Backwards

时间窗: Up to 3 hours prior to discharge

Cognitive Function as measured by Rey Auditory Verbal Learning Long Delay and Recognition

时间窗: Up to 3 hours prior to discharge

Cognitive Function as measured by Rey Auditory Verbal Learning Long Delay

时间窗: Up to 3 hours prior to discharge

Cognitive Function as measured by Frontal Assessment Battery

时间窗: Up to 3 hours prior to discharge

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Josephson, MS MD

Professor of Medicine

University Hospitals Cleveland Medical Center

研究点 (1)

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