Intracranial Atherosclerosis and Depression After Coronary Artery Bypass Graft

Depression Clinical Trial

— NOAHS  

Official title:

Intracranial Atherosclerosis and Predictors of Post-CABG Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01838356
• Other study ID #: 1202009664
• Status: Completed
• Phase: N/A
• First received: April 15, 2013
• Last updated: January 12, 2018
• Start date: September 2012

Study information

• Verified date: January 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Depression
• Depressive Disorder
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	The Johns Hopkins University	Baltimore	Maryland
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-surgical intracranial atherosclerosis as measured by transcranial doppler ultrasound relative to depressive symptoms post-surgically as measured by DISH.		12 months
Secondary	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.	12 months