Cognitive Function in Adults With Cardiac Disease

NCT01043315 | Completed

• 1 other identifier: 05-09-25
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

Cognitive Function; Cognitive Impairment; Hospitalization; Cardiac Disease

Outcome Measures

Primary Outcomes (7)

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

  Up to 3 hours prior to discharge

• Cognitive Function as measured by Rey Auditory Verbal Learning

  Up to 3 hours prior to discharge

• Cognitive Function as measured by Trails testing

  Up to 3 hours prior to discharge

• Cognitive Function as measured by Digit Span Backwards

  Up to 3 hours prior to discharge

• Cognitive Function as measured by Rey Auditory Verbal Learning Long Delay

  Up to 3 hours prior to discharge

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

  Up to 3 hours prior to discharge

• Cognitive Function as measured by Frontal Assessment Battery

  Up to 3 hours prior to discharge

Study Arms (1)

Hospitalized Cardiac Patient

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Admission to the Cardiac Intensive Care Unite for acute cardiological issues during time of enrollment.
• Patients with NYHA class I, II, III, and IV.
• years or older and must be awake and conversant at time of enrollment.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Heart Diseases

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cardiovascular Diseases

Study Officials

• Richard Josephson, MS, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 6, 2010
• Study Start: July 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 22, 2022

Record last verified: 2022-04

Locations

US (1)