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Prevalence & Progression of Subclinical Atherosclerosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006503
First Posted: November 17, 2000
Last Update Posted: May 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Rush University Medical Center
  Purpose
To evaluate subclinical atherosclerotic disease in menopausal women.

Condition
Atherosclerosis Cardiovascular Diseases Coronary Arteriosclerosis Carotid Artery Diseases Menopause

Study Type: Observational

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006503


Sponsors and Collaborators
Rush University Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Lynda Powell Rush-Presbyterian-St. Lukes Medical Center
OverallOfficial: Kim Tyrrell University of Pittsburgh
  More Information

ClinicalTrials.gov Identifier: NCT00006503     History of Changes
Other Study ID Numbers: 944
R01HL065581 ( U.S. NIH Grant/Contract )
First Submitted: November 16, 2000
First Posted: November 17, 2000
Last Update Posted: May 1, 2014
Last Verified: April 2008

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