Cognitive Function in Adults With Cardiac Disease

NCT ID: NCT01043315

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-12-31

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.

Conditions

Cognitive Impairment; Cardiac Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Hospitalized Cardiac Patient

Adults admitted to Coronary intensive unit being treated for acute cardiovascular conditions

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Richard Josephson, MS MD

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Josephson, MS, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals of Cleveland

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

05-09-25

Identifier Type: -

Identifier Source: org_study_id