Prevalence & Progression of Subclinical Atherosclerosis

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00006503
First received: November 16, 2000
Last updated: April 29, 2014
Last verified: April 2008
  Purpose

To evaluate subclinical atherosclerotic disease in menopausal women.


Condition
Atherosclerosis
Cardiovascular Diseases
Coronary Arteriosclerosis
Carotid Artery Diseases
Menopause

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Study Start Date: August 2000
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

Decreased ovarian function and premenopausal obesity are likely the primary determinants of early coronary atherosclerosis as measured by calcification on EBCT. Aortic calcification occurs earlier than coronary calcification, may predict coronary calcification, and is expected to be the best marker of risk associated with traditional factors in these younger women. Preliminary data indicate that changes in coronary and aortic calcification can be observed over short periods of time in these women. A period of diminishing estrogen levels is the optimum time to observe changes in endothelial function which likely precede measurable atherosclerosis and thus may be the earliest markers for disease potential. Vascular stiffness, a marker for the biologic aging of the vascular system, is highly correlated with measures of insulin sensitivity which is altered in women at mid-life in conjunction with increases in central adiposity. Racial differences in disease prevalence and the relative importance of certain risk factors are likely.

DESIGN NARRATIVE:

Subclinical atherosclerosis will be evaluated in 728 women (305 African American, 423 Caucasian) enrolled in the Pittsburgh and Chicago sites of the Study of Women's Health Across the Nation (SWAN), a multicenter study characterizing the biological and psychosocial antecedents and sequellae of menopause. The extent to which diminishing ovarian function affects vascular function and accelerates the development of atherosclerosis in the coronary arteries, aorta and carotid arteries will be evaluated. Serial measures of coronary and aortic calcification (by electron beam computed tomography [EBCT] ), carotid atherosclerosis, endothelial function and aortic stiffening will be performed two years apart. The prevalence and progression of subclinical atherosclerosis will be evaluated in relation to serial measures of ovarian function, psychosocial and behavioral factors, markers of clotting and inflammation as well as traditional cardiovascular risk factors, all collected in SWAN. The study is conducted jointly by Dr. Lynda Powell (R01HL65581) at Rush-Presbyterian-St. Luke's Medical Center in Chicago and Dr. Kim Tyrrell (R01HL65591) at the University of Pittsburgh.

  Eligibility

Genders Eligible for Study:   Female
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: NCT00006503

Sponsors and Collaborators
Rush University Medical Center
Investigators
Investigator: Lynda Powell Rush-Presbyterian-St. Lukes Medical Center
Investigator: Kim Tyrrell University of Pittsburgh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006503     History of Changes
Other Study ID Numbers: 944, R01HL065581
Study First Received: November 16, 2000
Last Updated: April 29, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Carotid Artery Diseases
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coronary Disease
Heart Diseases

ClinicalTrials.gov processed this record on July 24, 2014