Coronary Heart Disease Incidence: Depression & Inflammation Risk

Sponsor

Columbia University (Other)

Overall Status

Completed

CT.gov ID

NCT00241774

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

3,227

Enrollment

Location

Duration (Months)

56.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Coronary Disease Heart Diseases Depression Inflammation

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.

Study Design

Study Type:

Observational

Actual Enrollment :

3227 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Coronary Heart Disease Incidence: Depression & Inflammation Risk

Study Start Date :

Aug 1, 2005

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.