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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Yale University
Sponsor:
Information provided by (Responsible Party):
Hochang Benjamin Lee, Yale University
ClinicalTrials.gov Identifier:
NCT01838356
First received: April 15, 2013
Last updated: April 23, 2013
Last verified: April 2013

April 15, 2013
April 23, 2013
September 2012
February 2015   (final data collection date for primary outcome measure)
Pre-surgical intracranial atherosclerosis as measured by transcranial doppler ultrasound relative to depressive symptoms post-surgically as measured by DISH. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01838356 on ClinicalTrials.gov Archive Site
Examine neurocognitive function relative to post-CABG depression through a series of neurocognitive tests. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Neurocognitive tests are aimed at evaluating memory, processing speed, and global cognition.
Same as current
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Intracranial Atherosclerosis and Depression After Coronary Artery Bypass Graft
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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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.

  • Depression
  • Intracranial Atherosclerosis
  • Coronary Artery Disease
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No treatment.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
February 2015   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
United States
 
NCT01838356
MH085740
No
Hochang Benjamin Lee, Yale University
Yale University
Not Provided
Not Provided
Yale University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP