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OpenTrials
Completed

NCT Number: NCT01043315

Cognitive Function in Adults With Cardiac Disease

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.

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Key information

Conditions

Cognitive Impairment Cardiac Disease Cardiovascular Diseases Cognition Disorders Cognitive Dysfunction Heart Diseases Mental Disorders Neurocognitive Disorders

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: Up to 3 hours prior to discharge

  2. Cognitive Function as measured by Rey Auditory Verbal Learning

    Time frame: Up to 3 hours prior to discharge

  3. Cognitive Function as measured by Trails testing

    Time frame: Up to 3 hours prior to discharge

  4. Cognitive Function as measured by Digit Span Backwards

    Time frame: Up to 3 hours prior to discharge

  5. Cognitive Function as measured by Rey Auditory Verbal Learning Long Delay

    Time frame: Up to 3 hours prior to discharge

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

    Time frame: Up to 3 hours prior to discharge

  7. Cognitive Function as measured by Frontal Assessment Battery

    Time frame: Up to 3 hours prior to discharge

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Acronym: TimePoints

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 6, 2010
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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