Carotid Atherosclerosis Follow-up Study

May 12, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
To determine whether the degree of carotid artery atherosclerosis, as measured by B-mode ultrasound, predicts the development of myocardial infarction, stroke, and all-cause mortality in patients with angiographically defined coronary status. Also, to quantify the rate of progression of carotid artery disease and to evaluate the risk factors associated with progression of carotid atherosclerosis.

Study Overview

Status

Completed

Conditions

Detailed Description

BACKGROUND:

Although angiographic evidence of coronary atherosclerosis is one of the best predictors of clinical events, non-invasive imaging of this arterial bed is not yet possible. The availability of non-invasive methods for imaging the carotid arteries, and the intra-individual similarity of extent of disease in the coronary and carotid arteries provides rationale for this study that assesses the usefulness of B-mode ultrascan evaluation of extracranial carotid artery atherosclerosis as an independent predictor of clinical sequelae such as fatal and non-fatal myocardial infarction and stroke.

DESIGN NARRATIVE:

Pilot data from an ongoing case-comparison study of risk factors for coronary and carotid atherosclerosis as defined by angiography and B-mode ultrasound provided a background for this project. Patients from the pilot study were used in this study. Beginning in 1986, traditional risk factors such as lipids, lipoproteins, blood pressure, diabetes, and smoking were measured as were non-traditional risk factors such as apolipoproteins and genetic markers. The cohort was followed for 3.5 to 8.5 years for incidence of clinical events. Multivariate techniques were used to relate disease or risk factor status to all-cause mortality, fatal and non-fatal myocardial infarction, and fatal and non-fatal stroke. The same subjects were re-evaluated periodically by B-mode for extent of carotid atherosclerosis. A fifty percent random sample of patients positive for both cerebrovascular disease and coronary artery disease and a fifty percent random sample of patients negative for both cerebrovascular disease and coronary artery disease had repeat B-mode measurements at 2.5 years. All patients surviving at the end of five years had repeat B-mode scans.

The study was renewed in 1996 through April 1999 to conduct a longitudinal study testing the following hypotheses: 1.) Incidence of cardiovascular events (bypass surgery, angioplasty, fatal and non-fatal myocardial infarction, and stroke and endarterectomy) in men and women with extensive carotid wall thickening (CWT) at baseline exceeds that of those with less extensive baseline carotid wall thickening; the relation of carotid wall thickening to outcome is independent of coronary artery disease and/or coronary artery disease risk factors; and, 2.) carotid wall thickening progresses more rapidly in males and females with coronary artery disease and/or coronary artery disease risk factors than in coronary artery disease/risk factor free controls.

The investigators intend to: 1) follow-up a cohort of 670 individuals with defined coronary anatomy, extent of carotid wall thickening, and coronary artery disease risk factors over 5-10 years for fatal and non-fatal cardiovascular events. Coronary artery disease, carotid wall thickening, and coronary artery disease risk factor status at accession will be related to outcome; and, 2.) In a separate (new) cohort of 280 volunteers with and without coronary artery disease they will evaluate carotid wall thickening yearly for three years, and use multivariable analysis to relate accession status to progression rate. Availability of a unique sample of patients largely already characterized for coronary status (at angiography), coronary artery disease risk factors, and carotid wall thickening, and development of B-mode methods for quantifying carotid wall thickening and biostatistical approaches for quantifying progression of carotid wall thickening over a short time span (three years) provide opportunity for this project. Recent pilot data support its feasibility.

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, Bowman Gray School of Medicine

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

July 1, 1986

Study Completion (Actual)

April 1, 1999

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)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

November 1, 2002

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1067
  • R01HL035333 (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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