Arterial Endothelial Function--An Epidemiologic Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Trudy L Burns, University of Iowa
ClinicalTrials.gov Identifier:
NCT00005545
First received: May 25, 2000
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

To determine if risk factors measured in childhood can predict the development of atherosclerotic coronary and carotid artery disease in adulthood.


Condition
Cardiovascular Diseases
Heart Diseases
Coronary Arteriosclerosis
Carotid Artery Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Arterial Endothelial Function--An Epidemiologic Study

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Flow-mediated dilatation [ Time Frame: 1999 to 2008 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Stored plasma and DNA samples


Enrollment: 600
Study Start Date: December 1998
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

Many young adult subjects have some degree of atherosclerotic coronary and carotid artery disease and experience no symptoms. As time passes, many die suddenly and unexpectedly and only limited therapeutic process begins in youth, a measure of the early manifestations of atherosclerosis may have the potential of identifying subjects at risk for premature coronary and carotid occlusive vascular disease when therapeutic options can be administered. Impaired brachial artery flow mediated dilatory (FMD) capacities have been shown to exist in children and young adults with hypercholesterolemia, hyperhomocysteinemia, diabetes and in those who smoke. Impaired brachial artery FMD has been shown to related to impaired endothelial function, which is an early manifestation of the atherosclerotic process. If impaired brachial artery FMD is a predictor of the process, then it may be used to non-invasively assess atherosclerosis early in its development and to evaluate the effect of therapeutic interventions.

DESIGN NARRATIVE:

In this longitudinal study using previously studied members of the Muscatine study, measurements are made of contemporaneous risk factors, and brachial artery FMD, along with coronary artery calcification (CAC) and carotid artery intimal-medial thickness (IMT) (the latter two established measures of early atherosclerosis) and again three years later. The effort is designed to examine the following hypotheses: 1) Established risk factor levels measured in childhood, adulthood and across the years form childhood through adulthood are predictive of brachial artery flow mediated dilatory (FMD) capacities; 2) Putative risk factor levels measured in adulthood are related to the degree of brachial artery FMD, CAC and carotid artery IMT; 3) Brachial artery FMD, CAC and carotid artery IMTare related in adults; and 4) Brachial artery FMD is predictive of increased carotid artery IMT.

  Eligibility

Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Muscatine Study Longitudinal Adult Cohort - representative sample of childhood participants from the 1970s

Criteria

Participated in at least on school survey examination, at least one young-adult follow-up survey examination and the first Longitudinal Adult Cohort examination

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00005545

Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Ronald Lauer University of Iowa
  More Information

Publications:
Responsible Party: Trudy L Burns, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT00005545     History of Changes
Other Study ID Numbers: 5088, R37HL061857
Study First Received: May 25, 2000
Last Updated: December 10, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 30, 2014