- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01043315
Cognitive Function in Adults With Cardiac Disease (TimePoints)
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:
- The degree of cognitive function for patients hospitalized in a CICU will be below the scores for normal functioning adults.
- Patients with acute cardiovascular conditions will score differently in cognitive functioning at various times throughout their hospitalization.
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals of Cleveland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Hospitalized Cardiac Patient
Adults admitted to Coronary intensive unit being treated for acute cardiovascular conditions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cognitive Function as measured by Modified Mini Mental Status (3MS) Examination
Time Frame: Up to 3 hours prior to discharge
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Up to 3 hours prior to discharge
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Cognitive Function as measured by Rey Auditory Verbal Learning
Time Frame: Up to 3 hours prior to discharge
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Up to 3 hours prior to discharge
|
Cognitive Function as measured by Trails testing
Time Frame: Up to 3 hours prior to discharge
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Up to 3 hours prior to discharge
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Cognitive Function as measured by Digit Span Backwards
Time Frame: Up to 3 hours prior to discharge
|
Up to 3 hours prior to discharge
|
Cognitive Function as measured by Rey Auditory Verbal Learning Long Delay
Time Frame: Up to 3 hours prior to discharge
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Up to 3 hours prior to discharge
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Cognitive Function as measured by Rey Auditory Verbal Learning Long Delay and Recognition
Time Frame: Up to 3 hours prior to discharge
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Up to 3 hours prior to discharge
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Cognitive Function as measured by Frontal Assessment Battery
Time Frame: Up to 3 hours prior to discharge
|
Up to 3 hours prior to discharge
|
Collaborators and Investigators
Investigators
- Principal Investigator: Richard Josephson, MS, MD, University Hospitals Cleveland Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-09-25
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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