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: May 12, 2016
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
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.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

  Eligibility

Ages Eligible for Study:   65 Years to 100 Years   (Adult, Senior)
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
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Russell Tracy University of Vermont
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00005692     History of Changes
Other Study ID Numbers: 4222  R01HL046696 
Study First Received: May 25, 2000
Last Updated: May 12, 2016
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 21, 2016