DepressionNOAHSNCT01838356
Intracranial Atherosclerosis and Depression After Coronary Artery Bypass Graft
An observational study of Depression and Intracranial Atherosclerosis, run by Yale University at 2 sites in United States.
Trial summary
The purpose of the study is to examine if blood flow in the brain before coronary artery bypass graft surgery has an effect on depression after surgery. The main hypothesis of the study states that pre-surgical blood flow in the brain will be an independent risk factor for depression after surgery after adjusting for… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Depression, Intracranial Atherosclerosis, Coronary Artery Disease
- How many people
- 169 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to Aug 2016
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population for this study will be drawn from cardiac surgery patients at a university-based hospital who will undergo coronary artery bypass graft (CABG) surgery.
Who may be able to join
- Age: 40 years or older
- Will be having CABG surgery at the Yale New Haven Hospital
- Be able to provide informed consent
- Have a household telephone
- A fluent English speaker, and possessing no communication barrier
- Be able to come to the study site or to have the study team come to his/her home.
- Has a family member or partner/ friend who could provide collateral information
Who cannot join
- Has had previous CABG surgery
- History of dementia diagnosis or cognitive impairment (CDR >/= 1)
- Auditory or visual impairment that would interfere with study procedures
- Active alcohol or substance abuse problem based CAGE-AID (endorsing two or more items)
- History of Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, or any Psychotic Disorder by medical history or self-report.
- Presence of non-cardiovascular conditions likely to be fatal within 1 year
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Johns Hopkins University
Baltimore, Maryland, 21218
Yale University School of Medicine
New Haven, Connecticut, 06510
About this study
Official title: Intracranial Atherosclerosis and Predictors of Post-CABG Depression
The purpose of the study is to examine if blood flow in the brain before coronary artery bypass graft surgery has an effect on depression after surgery.
The main hypothesis of the study states that pre-surgical blood flow in the brain will be an independent risk factor for depression after surgery after adjusting for other risk factors such as gender, pre-CABG depression, social support, medical comorbidity burden, socioeconomic status, and neuroticism.
- Keywords
- Depression, Vascular depression, Intracranial atherosclerosis, Coronary artery disease, Coronary artery bypass graft, Cognitive impairment
- Medical subject headings
- Depression, Intracranial Arteriosclerosis, Coronary Artery Disease, Vascular Depression, Cognitive Dysfunction
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 |
|---|---|---|
| No treatment. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-surgical intracranial atherosclerosis as measured by transcranial doppler ultrasound relative to depressive symptoms post-surgically as measured by DISH.
Measured: 12 months
Secondary outcomes (1)
Examine neurocognitive function relative to post-CABG depression through a series of neurocognitive tests.
Neurocognitive tests are aimed at evaluating memory, processing speed, and global cognition.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startSep 2012
- Primary completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838356
- Sponsor's protocol ID
- 1202009664
- Acronym
- NOAHS
- Status last verified
- Jan 2018
- First submitted
- 15 Apr 2013
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Choi JJ, Kukla B, Walsh P, Oldham MA, Lee HB. Functional, cognitive, and cerebrovascular aspects of depression before coronary artery bypass graft surgery: Testing the vascular depression hypothesis. Int J Geriatr Psychiatry. 2023 Sep;38(9):e6000. doi: 10.1002/gps.6000.
PubMed 37684728Oldham MA, Hawkins KA, Yuh DD, Dewar ML, Darr UM, Lysyy T, Lee HB. Cognitive and functional status predictors of delirium and delirium severity after coronary artery bypass graft surgery: an interim analysis of the Neuropsychiatric Outcomes After Heart Surgery study. Int Psychogeriatr. 2015 Dec;27(12):1929-38. doi: 10.1017/S1041610215001477. Epub 2015 Oct 2.
PubMed 26423721
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracranial Atherosclerosis and Predictors of Post-CABG Depression
- ClinicalTrials.gov ID
- NCT01838356
- Acronym / sponsor ID
- NOAHS / 1202009664
- Keywords
- Depression, Vascular depression, Intracranial atherosclerosis, Coronary artery disease, Coronary artery bypass graft, Cognitive impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Aug 2016 (actual)
- First posted
- 24 Apr 2013 (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 the study is to examine if blood flow in the brain before coronary artery bypass graft surgery has an effect on depression after surgery.
The main hypothesis of the study states that pre-surgical blood flow in the brain will be an independent risk factor for depression after surgery after adjusting for other risk factors such as gender, pre-CABG depression, social support, medical comorbidity burden, socioeconomic status, and neuroticism.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment. | – | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population for this study will be drawn from cardiac surgery patients at a university-based hospital who will undergo coronary artery bypass graft (CABG) surgery.
Key inclusion criteria (7 listed)
- Age: 40 years or older
- Will be having CABG surgery at the Yale New Haven Hospital
- Be able to provide informed consent
- Have a household telephone
- A fluent English speaker, and possessing no communication barrier
Key exclusion criteria (6 listed)
- Has had previous CABG surgery
- History of dementia diagnosis or cognitive impairment (CDR >/= 1)
- Auditory or visual impairment that would interfere with study procedures
- Active alcohol or substance abuse problem based CAGE-AID (endorsing two or more items)
- History of Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, or any Psychotic Disorder by medical history or self-report.
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
Pre-surgical intracranial atherosclerosis as measured by transcranial doppler ultrasound relative to depressive symptoms post-surgically as measured by DISH.
Time frame: 12 months
1 secondary outcome
Examine neurocognitive function relative to post-CABG depression through a series of neurocognitive tests.
Time frame: 12 months
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 17 Jan 2018.
- Derived from this study: PubMed 37684728Choi JJ, Kukla B, Walsh P, Oldham MA, Lee HB. Functional, cognitive, and cerebrovascular aspects of depression before coronary artery bypass graft surgery: Testing the vascular depression hypothesis. Int J Geriatr Psychiatry. 2023 Sep;38(9):e6000. doi: 10.1002/gps.6000.
- Derived from this study: PubMed 26423721Oldham MA, Hawkins KA, Yuh DD, Dewar ML, Darr UM, Lysyy T, Lee HB. Cognitive and functional status predictors of delirium and delirium severity after coronary artery bypass graft surgery: an interim analysis of the Neuropsychiatric Outcomes After Heart Surgery study. Int Psychogeriatr. 2015 Dec;27(12):1929-38. doi: 10.1017/S1041610215001477. Epub 2015 Oct 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Intracranial Atherosclerosis, run by Yale University at 2 sites 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 7 inclusion and 6 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 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Pre-surgical intracranial atherosclerosis as measured by transcranial doppler ultrasound relative to depressive symptoms post-surgically as measured by DISH. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01838356, which also lists 2 linked publications.
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 17 Jan 2018.