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Inflammation Markers Over Time in Cardiovascular Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00005692
Enrollment
Unknown
Registered
2000-05-26
Start date
1992-04-30
Completion date
2002-11-30
Last updated
2016-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Coronary Disease, Heart Diseases, Inflammation, Thrombosis

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 1.2, 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 Lp(a). A case/control 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.

Interventions

None listed

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
Lead SponsorNIH

Eligibility

Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

No eligibility criteria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026