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OpenTrials
Completed

NCT Number: NCT01838356

Intracranial Atherosclerosis and Depression After Coronary Artery Bypass Graft

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Intracranial Atherosclerosis and Predictors of Post-CABG Depression

Acronym: NOAHS

Important dates

Study start
2012
Primary completion
2016
First posted
Apr 24, 2013
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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