Cognitive Function in Adults With Cardiac Disease

Cognitive Impairment Clinical Trial

— TimePoints  

Official title:

Cognitive Function in Adults With Cardiac Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043315
• Other study ID #: 05-09-25
• Status: Completed
• Start date: July 2009
• Est. completion date: December 2010

Study information

• Verified date: April 2022
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Disease
• Cognitive Dysfunction
• Cognitive Impairment
• Heart Diseases

Locations

Country	Name	City	State
United States	University Hospitals of Cleveland	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Function as measured by Modified Mini Mental Status (3MS) Examination		Up to 3 hours prior to discharge
Primary	Cognitive Function as measured by Rey Auditory Verbal Learning		Up to 3 hours prior to discharge
Primary	Cognitive Function as measured by Trails testing		Up to 3 hours prior to discharge
Primary	Cognitive Function as measured by Digit Span Backwards		Up to 3 hours prior to discharge
Primary	Cognitive Function as measured by Rey Auditory Verbal Learning Long Delay		Up to 3 hours prior to discharge
Primary	Cognitive Function as measured by Rey Auditory Verbal Learning Long Delay and Recognition		Up to 3 hours prior to discharge
Primary	Cognitive Function as measured by Frontal Assessment Battery		Up to 3 hours prior to discharge