Intracranial Atherosclerosis and Depression After Coronary Artery Bypass Graft (NOAHS)

January 12, 2018 updated by: Yale University

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

169

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School Of Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • The Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
No treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pre-surgical intracranial atherosclerosis as measured by transcranial doppler ultrasound relative to depressive symptoms post-surgically as measured by DISH.
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

April 15, 2013

First Submitted That Met QC Criteria

April 23, 2013

First Posted (Estimate)

April 24, 2013

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 12, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1202009664

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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