Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005191
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Clinical Course of Coronary Artery Disease Among Blacks
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2002-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the clinical course of coronary artery disease among Blacks receiving medical care for symptomatic heart diseases
Detailed Description:
BACKGROUND
The Black population has age-specific all causes mortality rates among adults which are up to 35 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 2806 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 1559 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 5600 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 Blackwhite 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
The Black population has age-specific all causes mortality rates among adults which are up to 35 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 2806 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 1559 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 5600 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 Blackwhite 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL038557 | NIH | None | httpsreporternihgovquickSearchR01HL038557 |