Arterial Endothelial Function--An Epidemiologic Study

NCT ID: NCT00005545

Last Updated: 2013-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

1998-12-31

Study Completion Date

2009-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Diseases Heart Diseases Coronary Arteriosclerosis Carotid Artery Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Iowa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Trudy L Burns

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ronald Lauer

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

References

Explore related publications, articles, or registry entries linked to this study.

Tschirren J, Lauer RM, Sonka M. Automated analysis of Doppler ultrasound velocity flow diagrams. IEEE Trans Med Imaging. 2001 Dec;20(12):1422-5. doi: 10.1109/42.974936.

Reference Type BACKGROUND
PMID: 11811841 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R37HL061857

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5088

Identifier Type: -

Identifier Source: org_study_id