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Coronary Heart Disease Incidence: Depression & Inflammation Risk

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Columbia University

Status

Completed

Conditions

Inflammation
Cardiovascular Diseases
Depression
Heart Diseases
Coronary Disease

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT00241774
R01HL080665 (U.S. NIH Grant/Contract)
AAAA2906

Details and patient eligibility

About

To examine the associations among depression, inflammation, and coronary heart disease using an existing data base and associated plasma samples.

Full 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.

Enrollment

3,227 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

3,227 participants in 1 patient group

NSHS95 samples
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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