Healia Clinical Trials Information Database

Coronary Heart Disease Incidence: Depression & Inflammation Risk

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

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.

Status: Completed (N/A). Started on August 1st, 2005.

Enrollment: 3227 subjects

Study Type: Observational

Study Design:

  • Observational Model: Cohort
  • Time Perspective: Prospective

Conditions:

Interventions:

  • Other: No intervention

Eligibility

No eligibility criteria

Gender

Both

Mininum Age

N/A

Maximum Age

N/A

Healthy Volunteers

No


Resources

Source: National Heart, Lung, and Blood Institute (NHLBI)

Authority: United States: Federal Government

Officials

  • Karina Davidson, PhD (Principal Investigator, Columbia University)

Sponsors

  • National Heart, Lung, and Blood Institute (NHLBI) (Lead Sponsor)

References

None.

Links

None.


Date Verified
June 1st, 2011
First Received
June 22nd, 2011
Last Changed
June 22nd, 2011

Information obtained from ClinicalTrials.gov on June 24, 2011. Link to the current ClinicalTrials.gov record.


All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


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