Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005692
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-05-25
Brief Title:
Inflammation Markers Over Time in Cardiovascular 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:
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 inflammation markers over time in cardiovascular disease To test the hypothesis that measures of coagulation and fibrinolysis correlate with the incidence of coronary heart disease CHD and other thrombosis related disorders and to help identify those individuals at greatest risk using the Cardiovascular Health Study CHS and Honolulu Heart Program HHP populations These two genetically distinct populations had different event rates for CHD and offered a unique opportunity to test associations that were uncovered by comparing results across populations
Detailed Description:
BACKGROUND
Coronary heart disease CHD and other thrombosis related disorders are a major source of morbidity and mortality in the United States and the world To a certain extent they are diseases of the elderly with the majority of overt CHD occurring in persons over the age of 65 Recently fibrinogen and factor VII have been implicated as independent CHD risk factors in middle age populations although causative roles have not been established These studies increased understanding of the relationship of thrombosis to cardiovascular risk
DESIGN NARRATIVE
Beginning in 1992 the study tested the hypothesis that measures of coagulation and fibrinolysis correlated with the incidence of coronary heart disease CHD and other thrombosis related disorders and identified those individuals at greatest risk using the Cardiovascular Health Study CHS and Honolulu Heart Program HHP populations These two genetically distinct populations had different event rates for CHD and offered a unique opportunity to test associations that were uncovered by comparing results across populations The study examined selected measures of coagulation and fibrinolysis in individuals 65 years and older measures of pro-coagulation factor antigen VII prothrombin fragment 12 fibrinopeptide A and thrombin - antithrombin III complex measures of coagulation inhibition protein C and protein S antithrombin III and the lipoprotein associated coagulation inhibitor LACI and measures of fibrinolysis plasminogen activator inhibitor-1 PAI-1 tissue plasminogen activator-PAI-1 complex plasmin-alpha-2 antiplasmin complex and Lpa
A casecontrol design was used to determine the relationship between the above measurements and the incidence of CHD and other thrombosis related disorders The short and medium term biological variability of the above measures was determined to aid in interpretation of observed differences Finally the distribution of the above measurements was established in both cohorts and their relationships to other variables in the extensive CHS and HHP data bases ascertained
The study was renewed in 1999 to determine inflammation markers over time in 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
Coronary heart disease CHD and other thrombosis related disorders are a major source of morbidity and mortality in the United States and the world To a certain extent they are diseases of the elderly with the majority of overt CHD occurring in persons over the age of 65 Recently fibrinogen and factor VII have been implicated as independent CHD risk factors in middle age populations although causative roles have not been established These studies increased understanding of the relationship of thrombosis to cardiovascular risk
DESIGN NARRATIVE
Beginning in 1992 the study tested the hypothesis that measures of coagulation and fibrinolysis correlated with the incidence of coronary heart disease CHD and other thrombosis related disorders and identified those individuals at greatest risk using the Cardiovascular Health Study CHS and Honolulu Heart Program HHP populations These two genetically distinct populations had different event rates for CHD and offered a unique opportunity to test associations that were uncovered by comparing results across populations The study examined selected measures of coagulation and fibrinolysis in individuals 65 years and older measures of pro-coagulation factor antigen VII prothrombin fragment 12 fibrinopeptide A and thrombin - antithrombin III complex measures of coagulation inhibition protein C and protein S antithrombin III and the lipoprotein associated coagulation inhibitor LACI and measures of fibrinolysis plasminogen activator inhibitor-1 PAI-1 tissue plasminogen activator-PAI-1 complex plasmin-alpha-2 antiplasmin complex and Lpa
A casecontrol design was used to determine the relationship between the above measurements and the incidence of CHD and other thrombosis related disorders The short and medium term biological variability of the above measures was determined to aid in interpretation of observed differences Finally the distribution of the above measurements was established in both cohorts and their relationships to other variables in the extensive CHS and HHP data bases ascertained
The study was renewed in 1999 to determine inflammation markers over time in 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 |
|---|---|---|---|
| R01HL046696 | NIH | None | httpsreporternihgovquickSearchR01HL046696 |