Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006403
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-10-12
Brief Title:
Inflammation Correlates and Prognosis in Framingham
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:
2005-03
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 determine the relation between cardiovascular disease risk factors and systemic markers of vascular inflammation in the Framingham Study cohort
Detailed Description:
BACKGROUND
Recent epidemiologic evidence suggests that inflammation plays a major role in the development of coronary artery disease High sensitivity C-reactive protein assays have been shown to be independent risk factors for the development of atherosclerosis Measurements of C-reactive protein also adds to the predictive value of lipid levels in determining the risk of cardiovascular disease Levels of inflammatory markers may also correlate with response to commonly used lipid lowering agents The exact role of inflammation in coronary artery disease is not clear however it has been suggested that inflammation may be a marker of subclinical cardiovascular disease or may indicate the presence of vulnerable plaque In addition to being a possible causative agent in the development of atherogenesis it has been postulated that inflammatory markers may reflect events that predict the development of myocardial events The fact that agents such as aspirin and pravastatin which are known to have anti-inflammatory effects are effective agents in the prevention of atherosclerosis suggests the possibility that prevention of inflammation may play an important role in reduction of risk for cardiovascular disease
DESIGN NARRATIVE
The study assessed inflammatory markers in 3765 men and women of the Framingham Study The markers included inflammatory C-reactive protein fibrinogen soluble intercellular adhesion molecule-1 endothelin-1 monocyte chemotactic protein-1 tumor necrosis factor-alpha and oxidative stress markers 8-epi-PGF 2alpha thromboxane B2 The relation between CVD risk factors and systemic markers of vascular inflammation was determined The relations between inflammatory markers endothelial dysfunction and subclinical disease were analyzed Markers of inflammation were related to prevalent and incident cardiovascular disease events adjusting for standard risk factors The central hypothesis was that inflammatory markers were independent risk factors for cardiovascular disease events with endothelial dysfunction operating in the causal pathway
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Recent epidemiologic evidence suggests that inflammation plays a major role in the development of coronary artery disease High sensitivity C-reactive protein assays have been shown to be independent risk factors for the development of atherosclerosis Measurements of C-reactive protein also adds to the predictive value of lipid levels in determining the risk of cardiovascular disease Levels of inflammatory markers may also correlate with response to commonly used lipid lowering agents The exact role of inflammation in coronary artery disease is not clear however it has been suggested that inflammation may be a marker of subclinical cardiovascular disease or may indicate the presence of vulnerable plaque In addition to being a possible causative agent in the development of atherogenesis it has been postulated that inflammatory markers may reflect events that predict the development of myocardial events The fact that agents such as aspirin and pravastatin which are known to have anti-inflammatory effects are effective agents in the prevention of atherosclerosis suggests the possibility that prevention of inflammation may play an important role in reduction of risk for cardiovascular disease
DESIGN NARRATIVE
The study assessed inflammatory markers in 3765 men and women of the Framingham Study The markers included inflammatory C-reactive protein fibrinogen soluble intercellular adhesion molecule-1 endothelin-1 monocyte chemotactic protein-1 tumor necrosis factor-alpha and oxidative stress markers 8-epi-PGF 2alpha thromboxane B2 The relation between CVD risk factors and systemic markers of vascular inflammation was determined The relations between inflammatory markers endothelial dysfunction and subclinical disease were analyzed Markers of inflammation were related to prevalent and incident cardiovascular disease events adjusting for standard risk factors The central hypothesis was that inflammatory markers were independent risk factors for cardiovascular disease events with endothelial dysfunction operating in the causal pathway
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
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 |
|---|---|---|---|
| R01HL064753 | NIH | None | httpsreporternihgovquickSearchR01HL064753 |