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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01838356
First Posted: April 24, 2013
Last Update Posted: February 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yale University
  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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 169
Study Start Date: September 2012
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838356


Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, Maryland
The Johns Hopkins University
Baltimore, Maryland, United States, 21218
Sponsors and Collaborators
Yale University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01838356     History of Changes
Other Study ID Numbers: MH085740
First Submitted: April 15, 2013
First Posted: April 24, 2013
Last Update Posted: February 6, 2017
Last Verified: February 2017

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

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