Cardiovascular DiseasesNCT00005191
Clinical Course of Coronary Artery Disease Among Blacks
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine the clinical course of coronary artery disease among Blacks receiving medical care for symptomatic heart diseases. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Myocardial Infarction
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1986to Mar 2001
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine the clinical course of coronary artery disease among Blacks receiving medical care for symptomatic heart diseases.
Read the 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.
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Myocardial Infarction, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1986
- Study completionMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005191
- Sponsor's protocol ID
- 1069
- Other IDs
- R01HL038557
- Status last verified
- Apr 2002
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
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.
PubMed 3493676Roig 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.
PubMed 3608117Castaner 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.
PubMed 3377351Ford 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.
PubMed 3354542Simmons 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.
PubMed 3394636Cooper 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.
PubMed 2137665Ghali 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.
PubMed 1632405Liao 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.
PubMed 1285782Liao 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.
PubMed 7641360Liao 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.
PubMed 7745772Mensah 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.
PubMed 7853322Fisher 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.
PubMed 9046551Cooper 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.
PubMed 8827151Liao 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.
PubMed 9060905Ghali 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.
PubMed 9626845
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Course of Coronary Artery Disease Among Blacks
- ClinicalTrials.gov ID
- NCT00005191
- Acronym / sponsor ID
- 1069
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1986
- Study completion
- Mar 2001 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Background: PubMed 3493676Simmons 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.
- Background: PubMed 3608117Roig 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.
- Background: PubMed 3377351Castaner 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.
- Background: PubMed 3354542Ford 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.
- Background: PubMed 3394636Simmons 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.
- Background: PubMed 2137665Cooper 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.
- Background: PubMed 1632405Ghali 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.
- Background: PubMed 1285782Liao 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.
- Background: PubMed 7641360Liao 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.
- Background: PubMed 7745772Liao 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.
- Background: PubMed 7853322Mensah 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.
- Background: PubMed 9046551Fisher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005191, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.