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Coronary Heart Disease Incidence: Depression & Inflammation Risk

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00241774
First Posted: October 19, 2005
Last Update Posted: February 5, 2016
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.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Karina Davidson, Columbia University
  Purpose
To examine the associations among depression, inflammation, and coronary heart disease using an existing data base and associated plasma samples.

Condition
Cardiovascular Diseases Coronary Disease Heart Diseases Depression Inflammation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Coronary Heart Disease Incidence: Depression & Inflammation Risk

Resource links provided by NLM:


Further study details as provided by Karina Davidson, Columbia University:

Biospecimen Retention:   Samples With DNA
In 1995, our study participants enrolled in the Nova Scotia Health Study (NSHS95). At the time of enrollment, epidemiologic data as well as blood samples were obtained. The participants have since been followed prospectively for a variety of health outcomes. We plan to assay stored blood samples collected in 1995 for markers of inflammation and link these results to existing epidemiologic and outcomes data, specifically the 7-year incidence of CAD events. Buffy coats were also obtained from the blood samples of the SAME participants for future DNA analysis.

Enrollment: 3227
Study Start Date: August 2005
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
NSHS95 samples
In 1995, our study participants enrolled in the Nova Scotia Health Study (NSHS95). At the time of enrollment, epidemiologic data as well as blood samples were obtained. The participants have since been followed prospectively for a variety of health outcomes. We plan to assay stored blood samples collected in 1995 for markers of inflammation and link these results to existing epidemiologic and outcomes data, specifically the 7- year incidence of CAD events.

Detailed Description:

BACKGROUND:

Classic risk factors for coronary heart disease (CHD) do not yet predict the majority of new cases. Of the novel risk factors recently explored, elevated depressive symptoms have been found in a number of prospective studies to predict new CHD cases, as have inflammatory markers, including high sensitivity C-Reactive Protein (CRP), interleukin-6 (IL-6), and intercellular adhesion molecule. Interestingly, depression and inflammatory markers have high covariation, and intervention studies indicate that reducing depression may reduce peripheral inflammation, while successfully treating inflammation may ameliorate depressive symptoms. It becomes critical then to know if these candidate CHD risk factors are independent or dependent of the other in the prediction of CHD incidence.

DESIGN NARRATIVE:

The study will determine if depressive symptoms and inflammatory markers are independent or dependent CHD risk factors, when controlling for the other known CAD risk factors. A population-based prospective study (the Nova Scotia Health Survey; NSHS95) was conducted almost 10 years ago, in which participants were randomly selected from the socialized medical registry, which includes all citizens. All classic CHD risk factors were obtained at baseline (age, sex, race, fasting lipids, diabetic status, family CHD history, resting blood pressure, exercise levels, body mass index, smoking status, and socioeconomic status). Depressive symptoms as assessed by the Center for Epidemiological Studies Depression scale were also obtained at baseline. Plasma blood samples were obtained and maintained in a -80 degree (Celsius) freezer. Participants gave permission for medical registry records to be linked to their survey data, so that objectively documented previous and future CAD events could be detected. The study will assay plasma samples for CRP, IL-6 and ICAM-1 and then statistically model the associations among depression, inflammation and CHD incidence.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In 1995, our study participants enrolled in the Nova Scotia Health Study (NSHS95). At the time of enrollment, epidemiologic data as well as blood samples were obtained. The participants have since been followed prospectively for a variety of health outcomes. We plan to assay stored blood samples collected in 1995 for markers of inflammation and link these results to existing epidemiologic and outcomes data, specifically the 7-year incidence of CAD events.
Criteria

Inclusion Criteria:

  • Age 18 and over
  • Able to speak English
  • Enrolled in the Nova Scotia Health Study (NSHS95)

Exclusion Criteria:

  • Pregnant
  • Active military personnel
  • Lived in Nova Scotia province for less than 3 months
  • Unable to provide informed consent
  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): NCT00241774


Locations
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Karina Davidson, PhD Columbia University
  More Information

Additional Information:
Responsible Party: Karina Davidson, Professor of Behavioral Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT00241774     History of Changes
Other Study ID Numbers: AAAA2906
R01HL080665 ( U.S. NIH Grant/Contract )
First Submitted: October 17, 2005
First Posted: October 19, 2005
Last Update Posted: February 5, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Heart Diseases
Depression
Depressive Disorder
Inflammation
Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases