Intracranial Atherosclerosis and Depression After Coronary Artery Bypass Graft

Completed

• Conditions: Coronary Artery Disease; Intracranial Atherosclerosis; Depression

• Registration Number: NCT01838356
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-04-15
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-24
• Primary Completion: 2016-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-12
• Last Update Posted: 2018-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pre-surgical intracranial atherosclerosis as measured by transcranial doppler ultrasound relative to depressive symptoms post-surgically as measured by DISH.	12 months

Secondary Outcome Measures

Name	Time	Method
Examine neurocognitive function relative to post-CABG depression through a series of neurocognitive tests.	12 months	Neurocognitive tests are aimed at evaluating memory, processing speed, and global cognition.

Trial Locations

Locations (2)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

The Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States