Clinical trial NCT01838356: Intracranial Atherosclerosis and Depression After Coronary Artery Bypass Graft
Official title: Intracranial Atherosclerosis and Predictors of Post-CABG Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Intracranial Atherosclerosis
Coronary Artery Disease
Keywords: Depression
Vascular depression
Intracranial atherosclerosis
Coronary artery disease
Coronary artery bypass graft
Cognitive impairment
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2013-04-24
Enrollment: 169
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 other risk factors such as gender, pre-CABG depression, social support, medical comorbidity burden, socioeconomic status, and neuroticism.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pre-surgical intracranial atherosclerosis as measured by transcranial doppler ultrasound relative to depressive symptoms post-surgically as measured by DISH.
timeFrame: 12 months
Secondary outcomes:
measure: Examine neurocognitive function relative to post-CABG depression through a series of neurocognitive tests.
timeFrame: 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
Study officials:
References:
citation: Oldham 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.