Arterial Endothelial Function--An Epidemiologic Study | NCT00005545

Studies
Arterial Endothelial Function--An Epidemiologic Study

NCT00005545

Sponsor

University of Iowa

Status

Completed

Last Update Posted

Dec 12, 2013Estimated

Enrollment

600Actual

Phase

Not provided

Conditions

Cardiovascular Diseases
Heart Diseases
Coronary Arteriosclerosis
Carotid Artery Diseases

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R37HL061857	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1998

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

May 25, 2000

First Submission Date that Met QC Criteria

May 25, 2000

First Posted Date

May 26, 2000Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2013

Last Update Posted Date

Dec 12, 2013Estimated

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

600Actual

Measure	Description	Time Frame
Flow-mediated dilatation		1999 to 2008

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Ronald Lauer	University of Iowa	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11811841	Background	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.

ID	Term
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D003324	Coronary Artery Disease
D002340	Carotid Artery Diseases

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases