Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037284
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
2002-05-16
Brief Title:
Behavioral and Immunological Factors in Coronary Disease
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To explore the immuneinflammatory processes as pathways between depressionexhaustion 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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL066149 | NIH | None | httpsreporternihgovquickSearchR01HL066149 |