Inflammation Markers Over Time in Cardiovascular Disease

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005692
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: March 2005
  Purpose

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.


Condition
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Thrombosis
Inflammation

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: April 1992
Estimated Study Completion Date: November 2002
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00005692

Sponsors and Collaborators
Investigators
Investigator: Russell Tracy University of Vermont
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00005692     History of Changes
Other Study ID Numbers: 4222
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Inflammation
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Thrombosis
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Embolism and Thrombosis

ClinicalTrials.gov processed this record on September 22, 2014