Cognitive ImpairmentTimePointsNCT01043315
Cognitive Function in Adults With Cardiac Disease
An observational study of Cognitive Impairment and Cardiac Disease, run by University Hospitals Cleveland Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cognitive Impairment, Cardiac Disease
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients hospitalized in the University Hospitals' (Cleveland, OH) coronary intensive unit (CICU) being treated for acute cardiovascular conditions
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals of Cleveland
Cleveland, Ohio, 44106
About this study
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:
Read more
- 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.
- Conditions
- Cognitive Impairment, Cardiac Disease
- Keywords
- Cognitive Function, Cognitive Impairment, Hospitalization, Cardiac Disease
- Medical subject headings
- Cognitive Dysfunction, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized Cardiac Patient | Adults admitted to Coronary intensive unit being treated for acute cardiovascular conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function as measured by Modified Mini Mental Status (3MS) Examination
Measured: Up to 3 hours prior to discharge
Cognitive Function as measured by Rey Auditory Verbal Learning
Measured: Up to 3 hours prior to discharge
Cognitive Function as measured by Trails testing
Measured: Up to 3 hours prior to discharge
Cognitive Function as measured by Digit Span Backwards
Measured: Up to 3 hours prior to discharge
Cognitive Function as measured by Rey Auditory Verbal Learning Long Delay
Measured: Up to 3 hours prior to discharge
Cognitive Function as measured by Rey Auditory Verbal Learning Long Delay and Recognition
Measured: Up to 3 hours prior to discharge
Cognitive Function as measured by Frontal Assessment Battery
Measured: Up to 3 hours prior to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startJul 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Josephson, MS MD, University Hospitals Cleveland Medical Center
- Investigators
- Richard Josephson, MS, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043315
- Sponsor's protocol ID
- 05-09-25
- Acronym
- TimePoints
- Status last verified
- Apr 2022
- First submitted
- 5 Jan 2010
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Function in Adults With Cardiac Disease
- ClinicalTrials.gov ID
- NCT01043315
- Acronym / sponsor ID
- TimePoints / 05-09-25
- Conditions
- Cognitive Impairment, Cardiac Disease
- Keywords
- Cognitive Function, Cognitive Impairment, Hospitalization, Cardiac Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized Cardiac Patient | – | –Adults admitted to Coronary intensive unit being treated for acute cardiovascular conditions |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients hospitalized in the University Hospitals' (Cleveland, OH) coronary intensive unit (CICU) being treated for acute cardiovascular conditions
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive Function as measured by Modified Mini Mental Status (3MS) Examination
Time frame: Up to 3 hours prior to discharge
Cognitive Function as measured by Rey Auditory Verbal Learning
Time frame: Up to 3 hours prior to discharge
Cognitive Function as measured by Trails testing
Time frame: Up to 3 hours prior to discharge
Cognitive Function as measured by Digit Span Backwards
Time frame: 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
Cognitive Function as measured by Rey Auditory Verbal Learning Long Delay and Recognition
Time frame: Up to 3 hours prior to discharge
Cognitive Function as measured by Frontal Assessment Battery
Time frame: Up to 3 hours prior to discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Josephson, MS, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment and Cardiac Disease, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function as measured by Modified Mini Mental Status (3MS) Examination (time frame: Up to 3 hours prior to discharge). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.