Clinical Course of Coronary Artery Disease Among Blacks
Primary Purpose
Cardiovascular Diseases, Coronary Disease, Myocardial Infarction
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005191
First Posted
May 25, 2000
Last Updated
February 17, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005191
Brief Title
Clinical Course of Coronary Artery Disease Among Blacks
Study Type
Observational
2. Study Status
Record Verification Date
April 2002
Overall Recruitment Status
Completed
Study Start Date
July 1986 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2001 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Disease, Myocardial Infarction, Heart Diseases
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
PubMed Identifier
3493676
Citation
Simmons BE, Castaner A, Santhanam V, Ghali J, Silverman NA, Goldfaden DM, Levitsky S, Cooper R, Ferlinz J. Outcome of coronary artery bypass grafting in black persons. Am J Cardiol. 1987 Mar 1;59(6):547-51. doi: 10.1016/0002-9149(87)91167-2.
Results Reference
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PubMed Identifier
3608117
Citation
Roig E, Castaner A, Simmons B, Patel R, Ford E, Cooper R. In-hospital mortality rates from acute myocardial infarction by race in U.S. hospitals: findings from the National Hospital Discharge Survey. Circulation. 1987 Aug;76(2):280-8. doi: 10.1161/01.cir.76.2.280.
Results Reference
background
PubMed Identifier
3377351
Citation
Castaner A, Simmons BE, Mar M, Cooper R. Myocardial infarction among black patients: poor prognosis after hospital discharge. Ann Intern Med. 1988 Jul 1;109(1):33-5. doi: 10.7326/0003-4819-109-1-33.
Results Reference
background
PubMed Identifier
3354542
Citation
Ford E, Cooper R, Simmons B, Katz S, Patel R. Sex differences in high density lipoprotein cholesterol in urban blacks. Am J Epidemiol. 1988 Apr;127(4):753-61. doi: 10.1093/oxfordjournals.aje.a114856.
Results Reference
background
PubMed Identifier
3394636
Citation
Simmons BE, Castaner A, Campo A, Ferlinz J, Mar M, Cooper R. Coronary artery disease in blacks of lower socioeconomic status: angiographic findings from the Cook County Hospital Heart Disease Registry. Am Heart J. 1988 Jul;116(1 Pt 1):90-7. doi: 10.1016/0002-8703(88)90254-2.
Results Reference
background
PubMed Identifier
2137665
Citation
Cooper RS, Simmons BE, Castaner A, Santhanam V, Ghali J, Mar M. Left ventricular hypertrophy is associated with worse survival independent of ventricular function and number of coronary arteries severely narrowed. Am J Cardiol. 1990 Feb 15;65(7):441-5. doi: 10.1016/0002-9149(90)90807-d.
Results Reference
background
PubMed Identifier
1632405
Citation
Ghali JK, Liao Y, Cooper RS, Cao G. Changes in pulmonary hemodynamics with aging in a predominantly hypertensive population. Am J Cardiol. 1992 Aug 1;70(3):367-70. doi: 10.1016/0002-9149(92)90621-5.
Results Reference
background
PubMed Identifier
1285782
Citation
Liao Y, Cooper RS, Ghali JK, Szocka A. Survival rates with coronary artery disease for black women compared with black men. JAMA. 1992 Oct 14;268(14):1867-71. Erratum In: JAMA 1993 Feb 17;269(7):870.
Results Reference
background
PubMed Identifier
7641360
Citation
Liao Y, Cooper RS, Mensah GA, McGee DL. Left ventricular hypertrophy has a greater impact on survival in women than in men. Circulation. 1995 Aug 15;92(4):805-10. doi: 10.1161/01.cir.92.4.805.
Results Reference
background
PubMed Identifier
7745772
Citation
Liao Y, Cooper RS, McGee DL, Mensah GA, Ghali JK. The relative effects of left ventricular hypertrophy, coronary artery disease, and ventricular dysfunction on survival among black adults. JAMA. 1995 May 24-31;273(20):1592-7.
Results Reference
background
PubMed Identifier
7853322
Citation
Mensah GA, Barkey NL, Cooper RS. Spectrum of hypertensive target organ damage in Africa: a review of published studies. J Hum Hypertens. 1994 Nov;8(11):799-808.
Results Reference
background
PubMed Identifier
9046551
Citation
Fisher SG, Cooper R, Weber L, Liao Y. Psychosocial correlates of chest pain among African-American women. Women Health. 1996;24(3):19-35. doi: 10.1300/j013v24n03_02.
Results Reference
background
PubMed Identifier
8827151
Citation
Cooper RS, Liao Y, Rotimi C. Is hypertension more severe among U.S. blacks, or is severe hypertension more common? Ann Epidemiol. 1996 May;6(3):173-80. doi: 10.1016/1047-2797(96)00009-9.
Results Reference
background
PubMed Identifier
9060905
Citation
Liao Y, Cooper RS, Durazo-Arvizu R, Mensah GA, Ghali JK. Prediction of mortality risk by different methods of indexation for left ventricular mass. J Am Coll Cardiol. 1997 Mar 1;29(3):641-7. doi: 10.1016/s0735-1097(96)00552-9.
Results Reference
background
PubMed Identifier
9626845
Citation
Ghali JK, Liao Y, Cooper RS. Influence of left ventricular geometric patterns on prognosis in patients with or without coronary artery disease. J Am Coll Cardiol. 1998 Jun;31(7):1635-40. doi: 10.1016/s0735-1097(98)00131-4.
Results Reference
background
PubMed Identifier
11800275
Citation
Liao Y, Ghali JK, Berzins L, Cooper RS. Coronary angiographic findings in African-American and white patients from a single institution. J Natl Med Assoc. 2001 Dec;93(12):465-74.
Results Reference
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Clinical Course of Coronary Artery Disease Among Blacks
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