Clinical Course of Coronary Artery Disease Among Blacks

To determine the clinical course of coronary artery disease among Blacks receiving medical care for symptomatic heart diseases.

Study Overview

Detailed Description

BACKGROUND:

The Black population has age-specific all causes mortality rates among adults which are up to 3.5 times higher than for whites. There remains a pressing need to improve detection and treatment of coronary artery disease among Blacks in an attempt to reduce these unfavorable racial differentials. Also, many fundamental advances in our understanding of atherosclerosis have come from the study of geographic pathology - the epidemiologic comparisons of population groups with widely varying distributions of risk factors. Two prominent features of the epidemiology of coronary artery disease among United States Blacks which are fertile grounds for such comparative studies are the high prevalence of hypertension and the increased susceptibility of Black women to this disease. Knowledge gained from these studies can potentially be applied to coronary artery disease in all human population groups, as has been done with work among the Masai, Seventh-Day Adventists, and other groups.

DESIGN NARRATIVE:

In this longitudinal study, patients were recruited from the adult Emergency Service of Cook County Hospital. Key end-points included: case fatality rates from acute events; long-term survival rates; sudden versus non-sudden death rates; occurrence of first myocardial infarction among patients with new onset angina; functional recovery after myocardial infarction and coronary artery bypass graft. Baseline data were collected in all groups and include: age, sex, education, weight, height, medical history, hyperlipidemia, alcohol and cigarette use, and medications. Both two-dimensional and M-mode echocardiograms were obtained and an exercise test performed. At the time of cardiac catheterization fasting blood samples were drawn for lipid analysis. Bi-plane ventriculography and cineangiography were performed. After discharge, patients returned to the clinic at three-month intervals for up to two years. Analyses were conducted on left ventricular hypertrophy and socioeconomic status as predictors of mortality. The two control groups permitted comparisons of baseline findings and end-points. One hundred and fifty patients from each of the control groups were followed long-term, primarily through surveillance of government vital status records. The study provided data on survival rates, incidence of new events, and mode of death, the roles of sex differences and hypertension in coronary artery disease, and the efficacy of coronary artery bypass surgery.

The study was renewed in FY 1993 to address a series of major questions related to the clinical epidemiology of coronary artery disease among Black women and to continue the on going study involving 2,806 Black men and women who had been enrolled in a hospital-based registry. An examination of the survival patterns and related risk factors in the cohort of 1,559 Black women was the primary focus of this project.

The study was renewed in 1996 to continue to follow the original cohort to examine the interaction of left ventricular hypertrophy (LVH) and mortality risk in the subgroup of patients with coronary heart disease, to investigate further the impact of left ventricular geometry on survival, and to define the prognostic significance of obesity. Also to enroll a new clinical cohort of 5,600 patients, approximately equally divided between Blacks and whites, from Louisiana State University (LSU) Medical Center. The survival patterns of these groups are compared directly, and the contribution of LVH to the Black:white differential estimated. The new cohort serves as a validation sample for the hypotheses derived from the original cohort.

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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

Primary Completion

December 8, 2022

Study Completion (Actual)

March 1, 2001

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)

February 18, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

April 1, 2002

More Information

Terms related to this study

Other Study ID Numbers

  • 1069
  • R01HL038557 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Myocardial Infarction

3
Subscribe