Vascular Disease--Structure/Function

March 15, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
To investigate the relationship of non-invasively measured flow-mediated brachial artery dilation with coronary artery disease (CAD).

Study Overview

Status

Completed

Conditions

Detailed Description

BACKGROUND:

This study meshed with a longitudinal case-control study, HL-35333, Carotid Atherosclerosis Follow-Up Study. HL-35333 comprised 280 individuals older than 45 equally divided between men and women, half with and half without CAD evaluated for risk factors at baseline and with completed follow-up with yearly B-mode for three years. The Carotid Atherosclerosis Follow-Up Study quantified the interassociations of angiographically defined coronary artery disease and CAD risk factors with progression. The NIH funded a continuation of this effort to review existing ultrasound tapes from this study in order to additionally evaluate the associations of all these factors with extracranial carotid arterial dimensions (ECAD: interadventitial and lumen diameters) and change in ECAD over time.

DESIGN NARRATIVE:

The study assessed brachial artery reactivity among 100 CAD subjects and 100 controls who had been previously enrolled in a study of the relationship between extracranial intima media thickness (ECIMT) as assessed by B mode ultrasonographic measurements and CAD status. Most subjects had three consecutive B mode measurements at 12 month intervals. These subjects had brachial artery reactivity measurements according to a standardized protocol. Linear regression analysis was used to relate brachial artery reactivity to CAD status, gender and risk factors as predictors. Interaction effects were also assessed between CAD status and other risk factors and also between gender and other risk factors. Similar analyses were performed to relate percent dilation to ECIMT measurements.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • John Crouse, III, Wake Forest University

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1998

Study Completion (Actual)

June 1, 2000

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimate)

May 26, 2000

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

April 1, 2004

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5024
  • R01HL059503 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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