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Clinical Trials/NCT01043315
NCT01043315
Completed
Not Applicable

Cognitive Function in Adults With Cardiac Disease

University Hospitals Cleveland Medical Center1 site in 1 country66 target enrollmentJuly 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Impairment
Sponsor
University Hospitals Cleveland Medical Center
Enrollment
66
Locations
1
Primary Endpoint
Cognitive Function as measured by Modified Mini Mental Status (3MS) Examination
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.
Registry
clinicaltrials.gov
Start Date
July 2009
End Date
December 2010
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Richard Josephson, MS MD

Professor of Medicine

University Hospitals Cleveland Medical Center

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Time Frame: Up to 3 hours prior to discharge

Cognitive Function as measured by Rey Auditory Verbal Learning

Time Frame: Up to 3 hours prior to discharge

Cognitive Function as measured by Trails testing

Time Frame: Up to 3 hours prior to discharge

Cognitive Function as measured by Digit Span Backwards

Time Frame: Up to 3 hours prior to discharge

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

Time Frame: Up to 3 hours prior to discharge

Cognitive Function as measured by Rey Auditory Verbal Learning Long Delay

Time Frame: Up to 3 hours prior to discharge

Cognitive Function as measured by Frontal Assessment Battery

Time Frame: Up to 3 hours prior to discharge

Study Sites (1)

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