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Clinical Trials/NCT01838356
NCT01838356CompletedNot Applicable

Intracranial Atherosclerosis and Predictors of Post-CABG Depression

Yale University2 sites in 1 country169 target enrollmentStarted: September 2012Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
169
Locations
2
Primary Endpoint
Pre-surgical intracranial atherosclerosis as measured by transcranial doppler ultrasound relative to depressive symptoms post-surgically as measured by DISH.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Pre-surgical intracranial atherosclerosis as measured by transcranial doppler ultrasound relative to depressive symptoms post-surgically as measured by DISH.

Time Frame: 12 months

Secondary Outcomes

  • Examine neurocognitive function relative to post-CABG depression through a series of neurocognitive tests.(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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