Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Clinical Course of Coronary Artery Disease Among Blacks

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005191
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: April 2002

May 25, 2000
June 23, 2005
July 1986
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00005191 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Course of Coronary Artery Disease Among Blacks
Not Provided

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

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.

Observational
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
  • Cardiovascular Diseases
  • Coronary Disease
  • Myocardial Infarction
  • Heart Diseases
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
March 2001
Not Provided

No eligibility criteria

Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00005191
1069
Not Provided
Not Provided
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
Not Provided
National Heart, Lung, and Blood Institute (NHLBI)
April 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP