Carotid Atherosclerosis Follow-up Study
Carotid Atherosclerosis Follow-up Study
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.
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.
No eligibility criteria