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

This study is currently recruiting participants.
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
  Purpose

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.


Condition
Depression
Intracranial Atherosclerosis
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intracranial Atherosclerosis and Predictors of Post-CABG Depression

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01838356

Locations
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact: Hochang B Lee, MD    203-785-2618      
Principal Investigator: Hochang B Lee, MD         
United States, Maryland
The Johns Hopkins University Terminated
Baltimore, Maryland, United States, 21218
Sponsors and Collaborators
Yale University
  More Information

No publications provided

Responsible Party: Hochang Benjamin Lee, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT01838356     History of Changes
Other Study ID Numbers: MH085740
Study First Received: April 15, 2013
Last Updated: April 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Depression
Vascular depression
Intracranial atherosclerosis
Coronary artery disease
Coronary artery bypass graft
Cognitive impairment

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Depression
Depressive Disorder
Intracranial Arteriosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 14, 2014