Clinical trial NCT01043315: Cognitive Function in Adults With Cardiac Disease
Official title: Cognitive Function in Adults With Cardiac Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Cardiac Disease
Keywords: Cognitive Function
Cognitive Impairment
Hospitalization
Cardiac Disease
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2010-01-06
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients hospitalized in the University Hospitals' (Cleveland, OH) coronary intensive unit (CICU) being treated for acute cardiovascular conditions

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.


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.

Primary outcomes:
measure: Cognitive Function as measured by Modified Mini Mental Status (3MS) Examination
timeFrame: Up to 3 hours prior to discharge
measure: Cognitive Function as measured by Rey Auditory Verbal Learning
timeFrame: Up to 3 hours prior to discharge
measure: Cognitive Function as measured by Trails testing
timeFrame: Up to 3 hours prior to discharge
measure: Cognitive Function as measured by Digit Span Backwards
timeFrame: Up to 3 hours prior to discharge
measure: Cognitive Function as measured by Rey Auditory Verbal Learning Long Delay
timeFrame: Up to 3 hours prior to discharge
measure: Cognitive Function as measured by Rey Auditory Verbal Learning Long Delay and Recognition
timeFrame: Up to 3 hours prior to discharge
measure: Cognitive Function as measured by Frontal Assessment Battery
timeFrame: Up to 3 hours prior to discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Richard Josephson, MS, MD
role: PRINCIPAL_INVESTIGATOR
References: