Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005496
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-05-25
Brief Title:
Inflammation Infection and Future Cardiovascular Risk
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:
2005-02
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 examine markers of underlying chronic inflammation and infection as potential risk factors for future myocardial infarction MI stroke CVA and venous thromboembolism VTE in plasma samples collected at baseline from healthy participants in the Physicians Health Study PHS
Detailed Description:
BACKGROUND
The PHS is a cohort which included 14916 men initially free of cardiovascular disease and cancer who provided plasma samples at study entry in 1982 These men were randomly assigned in a factorial design to aspirin or beta-carotene therapy and have been followed prospectively for the occurrence of vascular disease
DESIGN NARRATIVE
Employing a nested case-control design baseline plasma samples are assayed for four markers of inflammation interleukin-6 TNF-alpha soluble ICAM soluble VCAM and four markers of chronic infection antibody titers directed against Chlamydia pneumoniae Helicobacter pylori Herpes simplex virus and cytomegalovirus Case subjects are those study participants who have subsequently developed MI N550 CVA N400 or VTE N200 Control subjects are selected from those study participants who remained healthy during follow-up and are matched to the cases by age smoking status and follow-up time Data on usual cardiovascular risk factors lipid parameters and hemostatic markers of risk are already available in the PHS and will be used to evaluate the results for potential confounding and effect modification Since the PHS was a randomized trial of low-dose aspirin for its initial 5 years this cohort also provides the unique opportunity to investigate whether the use of an agent with anti-inflammatory properties modifies the risk of subsequent thrombosis among those with underlying inflammation Indeed this intriguing hypothesis has recently been raised regarding data relating another marker of inflammation C-reactive protein to future risks of myocardial infarction and stroke
These analyses will take advantage of an existing blood bank from a well-characterized large cohort with many years of follow-up and high quality end-point verification Thus this study could provide an efficient and cost-effective mechanism to evaluate the posited but unproven roles of inflammation and infection as risk factors for future cardiovascular disease
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
The PHS is a cohort which included 14916 men initially free of cardiovascular disease and cancer who provided plasma samples at study entry in 1982 These men were randomly assigned in a factorial design to aspirin or beta-carotene therapy and have been followed prospectively for the occurrence of vascular disease
DESIGN NARRATIVE
Employing a nested case-control design baseline plasma samples are assayed for four markers of inflammation interleukin-6 TNF-alpha soluble ICAM soluble VCAM and four markers of chronic infection antibody titers directed against Chlamydia pneumoniae Helicobacter pylori Herpes simplex virus and cytomegalovirus Case subjects are those study participants who have subsequently developed MI N550 CVA N400 or VTE N200 Control subjects are selected from those study participants who remained healthy during follow-up and are matched to the cases by age smoking status and follow-up time Data on usual cardiovascular risk factors lipid parameters and hemostatic markers of risk are already available in the PHS and will be used to evaluate the results for potential confounding and effect modification Since the PHS was a randomized trial of low-dose aspirin for its initial 5 years this cohort also provides the unique opportunity to investigate whether the use of an agent with anti-inflammatory properties modifies the risk of subsequent thrombosis among those with underlying inflammation Indeed this intriguing hypothesis has recently been raised regarding data relating another marker of inflammation C-reactive protein to future risks of myocardial infarction and stroke
These analyses will take advantage of an existing blood bank from a well-characterized large cohort with many years of follow-up and high quality end-point verification Thus this study could provide an efficient and cost-effective mechanism to evaluate the posited but unproven roles of inflammation and infection as risk factors for future cardiovascular disease
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 |
|---|---|---|---|
| R01HL058755 | NIH | None | httpsreporternihgovquickSearchR01HL058755 |