Behavioral and Immunological Factors in Coronary Disease
Primary Purpose
Cardiovascular Diseases, Coronary Disease, Heart Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00037284
First Posted
May 16, 2002
Last Updated
July 11, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00037284
Brief Title
Behavioral and Immunological Factors in Coronary Disease
Study Type
Observational
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To explore the immune/inflammatory processes as pathways between depression/exhaustion and coronary artery disease (CAD) progression.
Detailed Description
BACKGROUND:
Recent studies demonstrate that the immune system plays an important role in coronary artery disease (CAD). Research also shows that psychological factors such as major depression and acute mental stress are involved in the clinical progression of CAD. Depression is associated with higher levels of immune parameters that play a role in CAD (cytokines, markers of low grade inflammation, infectious pathogen burden, and adhesion molecules), and most of these measures also increase in response to acute physical and mental stress. The pathophysiological mechanisms linking depression and mental stress with adverse cardiovascular outcomes may therefore be mediated by immunological factors.
DESIGN NARRATIVE:
The study examines clinical outcomes in patients who undergo percutaneous coronary revascularization, because a major problem remains the frequent (20 percent-40 percent) occurrence of coronary restenosis and new cardiac events in the six months after the intervention. These adverse outcomes have substantial impact on the costs of medical care and patients' quality of life. Since previous research has not examined the role of behaviorally-induced changes in immune parameters in the prediction of CAD progression, the following immunological measures will be examined: cytokines (IL-1B, IL-4, IL-6, IFNy, TNFa), acute phase proteins (CRP, fibrinogen), lymphocyte counts and differential, adhesion molecules (ICAM-1, LFA, L-selectin), and a composite measure of pathogen burden (CMV, H. pylori, C. pneumoniae). Using a longitudinal design, this project will determine the time course of changes in depression and changes in immune parameters. Moreover, the present study will determine the contribution of behavioral and immunological factors in the clinical progression of coronary disease following coronary angioplasty. These data may therefore improve the identification of patients at risk for recurrent cardiac events and restenosis after coronary angioplasty, and provide further understanding of the pathophysiological mechanisms involved in coronary disease progression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Depression
7. Study Design
10. Eligibility
Sex
All
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willem Kop
Organizational Affiliation
Uniformed Services University of the Health Sciences
12. IPD Sharing Statement
Citations:
PubMed Identifier
11835923
Citation
Kop WJ, Gottdiener JS, Tangen CM, Fried LP, McBurnie MA, Walston J, Newman A, Hirsch C, Tracy RP. Inflammation and coagulation factors in persons > 65 years of age with symptoms of depression but without evidence of myocardial ischemia. Am J Cardiol. 2002 Feb 15;89(4):419-24. doi: 10.1016/s0002-9149(01)02264-0.
Results Reference
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PubMed Identifier
12831824
Citation
Kop WJ. The integration of cardiovascular behavioral medicine and psychoneuroimmunology: new developments based on converging research fields. Brain Behav Immun. 2003 Aug;17(4):233-7. doi: 10.1016/s0889-1591(03)00051-5.
Results Reference
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PubMed Identifier
15953799
Citation
Kop WJ, Gottdiener JS. The role of immune system parameters in the relationship between depression and coronary artery disease. Psychosom Med. 2005 May-Jun;67 Suppl 1:S37-41. doi: 10.1097/01.psy.0000162256.18710.4a.
Results Reference
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Behavioral and Immunological Factors in Coronary Disease
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