Cardiovascular DiseasesNCT00005198
Survival After Myocardial Infarction in A Biethnic Texas Community (Corpus Christi Heart Project)
An observational study of Cardiovascular Diseases and Hypertension, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine the natural history of coronary heart disease in the biethnic community of Corpus Christi, Texas. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Hypertension, Coronary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1987to Mar 1998
- 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 natural history of coronary heart disease in the biethnic community of Corpus Christi, Texas.
Read the detailed description
BACKGROUND:
The decline in coronary heart disease mortality in the United States may be due to decreasing incidence of clinically apparent coronary heart disease or increasing survival from its first clinical appearance or both. Prior to 1987, few data were available to confirm either one directly. However, increased risk, decreased medical care, or both may predispose the Mexican-American population to increased recurrence of myocardial infarction and decreased post myocardial infarction survival, and an overall greater mortality among survivors of myocardial infarction, than are observed for Anglos in the same community setting. The significance of the potential results lies most importantly in the following aspects of this research: estimation of the community-based incidence of hospitalization for suspect, definite or possible myocardial infarction; precise determination of recurrence rates and survival curves after myocardial infarction in community-wide hospital-based cohorts; analysis of the relation of the above to risk status as ascertained at hospitalization and to health care and preventive practices assessed periodically post-myocardial infarction; and comparison of these observations between Anglos and Mexican-Americans, a group of special interest and concern because of expected differences in natural history of coronary heart disease and near total lack of the relevant data.
DESIGN NARRATIVE:
Patients hospitalized for acute coronary heart disease (CHD) in seven acute care hospitals in Nueces County, Texas were identified by active concurrent case registration. Baseline data on clinical, prognostic and sociodemographic characteristics of these patients at the time of the event were collected from the medical record and by interview with the patient. Patients with events meeting diagnostic criteria for acute myocardial infarction (MI) were followed directly through contacts at three months post-discharge and at the anniversary of discharge thereafter to ascertain vital status and to collect information about recurrent myocardial infarction, other changes in health status, and health care practices in the interim. Endpoints included all-cause mortality and deaths attributed to coronary heart disease, and fatal and non-fatal myocardial infarction. Data analysis included examination of survival and recurrence of myocardial infarction for the entire cohort of myocardial infarction patients and within ethnic groups; evaluation of potential prognostic factors within and between ethnic groups; and comparison of survival and myocardial infarction recurrence between ethnic groups after adjustment for both baseline and time-dependent covariates.
The study was renewed in 1992 to continue to identify hospitalized MI and CHD mortality as well as angioplasty, and bypass surgery among Mexican-Americans and non-Hispanic Whites. The investigators calculated incidence rates for hospitalized MI, for the use of cardiac revascularization, and rates for post-MI mortality, and for both all cause and CHD mortality in the community. They also described trends in these aspects of CHD over an eight year period and determined if ethnic differences existed.
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, Hypertension, Coronary Disease, Myocardial Infarction
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 startApr 1987
- Study completionMar 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)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
- NCT00005198
- Sponsor's protocol ID
- 1077
- Other IDs
- R01HL038429
- Status last verified
- Aug 2001
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Goff DC Jr, Varas C, Ramsey DJ, Wear ML, Labarthe DR, Nichaman MZ. Mortality after hospitalization for myocardial infarction among Mexican Americans and non-Hispanic whites: the Corpus Christi Heart Project. Ethn Dis. 1993 Winter;3(1):55-63.
PubMed 8508105Orlander PR, Goff DC, Morrissey M, Ramsey DJ, Wear ML, Labarthe DR, Nichaman MZ. The relation of diabetes to the severity of acute myocardial infarction and post-myocardial infarction survival in Mexican-Americans and non-Hispanic whites. The Corpus Christi Heart Project. Diabetes. 1994 Jul;43(7):897-902. doi: 10.2337/diab.43.7.897.
PubMed 8013754Nichaman MZ, Wear ML, Goff DC Jr, Labarthe DR. Hospitalization rates for myocardial infarction among Mexican-Americans and non-Hispanic whites. The Corpus Christi Heart Project. Ann Epidemiol. 1993 Jan;3(1):42-8. doi: 10.1016/1047-2797(93)90008-r.
PubMed 8287155Goff DC Jr, Nichaman MZ, Ramsey DJ, Meyer PS, Labarthe DR. A population-based assessment of the use and effectiveness of thrombolytic therapy. The Corpus Christi Heart Project. Ann Epidemiol. 1995 May;5(3):171-8. doi: 10.1016/1047-2797(94)00103-z.
PubMed 7606305Blumberg MS. Re: "Greater case-fatality after myocardial infarction among Mexican Americans and women than among non-Hispanic whites and men: The Corpus Christi Heart Project". Am J Epidemiol. 1995 Mar 1;141(5):478-80. doi: 10.1093/oxfordjournals.aje.a117453. No abstract available.
PubMed 7794339Labarthe DR: Changing Patterns in the Epidemiology of Coronary Artery Disease: Trends in Survival After Myocardial Infarction. In: Long-Term Management of Patients After Myocardial Infarction. Kappagoda CT, Greenwood PV, (Eds), Pages 17-30, 1987
Annegers JF, Hauser WA, Shirts SB, Kurland LT. Factors prognostic of unprovoked seizures after febrile convulsions. N Engl J Med. 1987 Feb 26;316(9):493-8. doi: 10.1056/NEJM198702263160901.
PubMed 3807992Slater CH, Green LW, Vernon SW, Keith VM. Problems in estimating the prevalence of physical activity from national surveys. Prev Med. 1987 Jan;16(1):107-18. doi: 10.1016/0091-7435(87)90010-7.
PubMed 3823009Slater CH, Carlton B, Ramirez G, Ashton C: Heart Disease, Strategies for Prevention. Eval Health Prof, 10(3):255-286, 1987
Goff DC Jr, Ramsey DJ, Labarthe DR, Nichaman MZ. Greater case-fatality after myocardial infarction among Mexican Americans and women than among non-Hispanic whites and men. The Corpus Christi Heart Project. Am J Epidemiol. 1994 Mar 1;139(5):474-83. doi: 10.1093/oxfordjournals.aje.a117030.
PubMed 8154471Goff DC Jr, Ramsey DJ, Labarthe DR, Nichaman MZ. Acute myocardial infarction and coronary heart disease mortality among Mexican Americans and non-Hispanic whites in Texas, 1980 through 1989. Ethn Dis. 1993 Winter;3(1):64-9.
PubMed 8508106Goff DC, Nichaman MZ, Chan W, Ramsey DJ, Labarthe DR, Ortiz C. Greater incidence of hospitalized myocardial infarction among Mexican Americans than non-Hispanic whites. The Corpus Christi Heart Project, 1988-1992. Circulation. 1997 Mar 18;95(6):1433-40. doi: 10.1161/01.cir.95.6.1433.
PubMed 9118510Herholz H, Goff DC, Ramsey DJ, Chan FA, Ortiz C, Labarthe DR, Nichaman MZ. Women and Mexican Americans receive fewer cardiovascular drugs following myocardial infarction than men and non-Hispanic whites: the Corpus Christi Heart Project, 1988-1990. J Clin Epidemiol. 1996 Mar;49(3):279-87. doi: 10.1016/0895-4356(95)00572-2.
PubMed 8676174Farmer IP, Meyer PS, Ramsey DJ, Goff DC, Wear ML, Labarthe DR, Nichaman MZ. Higher levels of social support predict greater survival following acute myocardial infarction: the Corpus Christi Heart Project. Behav Med. 1996 Summer;22(2):59-66. doi: 10.1080/08964289.1996.9933765.
PubMed 8879457Goff DC Jr, Pandey DK, Chan FA, Ortiz C, Nichaman MZ. Congestive heart failure in the United States: is there more than meets the I(CD code)? The Corpus Christi Heart Project. Arch Intern Med. 2000 Jan 24;160(2):197-202. doi: 10.1001/archinte.160.2.197.
PubMed 10647758
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival After Myocardial Infarction in A Biethnic Texas Community (Corpus Christi Heart Project)
- ClinicalTrials.gov ID
- NCT00005198
- Acronym / sponsor ID
- 1077
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 1987
- Study completion
- Mar 1998 (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 natural history of coronary heart disease in the biethnic community of Corpus Christi, Texas.
Detailed description
BACKGROUND:
The decline in coronary heart disease mortality in the United States may be due to decreasing incidence of clinically apparent coronary heart disease or increasing survival from its first clinical appearance or both. Prior to 1987, few data were available to confirm either one directly. However, increased risk, decreased medical care, or both may predispose the Mexican-American population to increased recurrence of myocardial infarction and decreased post myocardial infarction survival, and an overall greater mortality among survivors of myocardial infarction, than are observed for Anglos in the same community setting. The significance of the potential results lies most importantly in the following aspects of this research: estimation of the community-based incidence of hospitalization for suspect, definite or possible myocardial infarction; precise determination of recurrence rates and survival curves after myocardial infarction in community-wide hospital-based cohorts; analysis of the relation of the above to risk status as ascertained at hospitalization and to health care and preventive practices assessed periodically post-myocardial infarction; and comparison of these observations between Anglos and Mexican-Americans, a group of special interest and concern because of expected differences in natural history of coronary heart disease and near total lack of the relevant data.
DESIGN NARRATIVE:
Patients hospitalized for acute coronary heart disease (CHD) in seven acute care hospitals in Nueces County, Texas were identified by active concurrent case registration. Baseline data on clinical, prognostic and sociodemographic characteristics of these patients at the time of the event were collected from the medical record and by interview with the patient. Patients with events meeting diagnostic criteria for acute myocardial infarction (MI) were followed directly through contacts at three months post-discharge and at the anniversary of discharge thereafter to ascertain vital status and to collect information about recurrent myocardial infarction, other changes in health status, and health care practices in the interim. Endpoints included all-cause mortality and deaths attributed to coronary heart disease, and fatal and non-fatal myocardial infarction. Data analysis included examination of survival and recurrence of myocardial infarction for the entire cohort of myocardial infarction patients and within ethnic groups; evaluation of potential prognostic factors within and between ethnic groups; and comparison of survival and myocardial infarction recurrence between ethnic groups after adjustment for both baseline and time-dependent covariates.
The study was renewed in 1992 to continue to identify hospitalized MI and CHD mortality as well as angioplasty, and bypass surgery among Mexican-Americans and non-Hispanic Whites. The investigators calculated incidence rates for hospitalized MI, for the use of cardiac revascularization, and rates for post-MI mortality, and for both all cause and CHD mortality in the community. They also described trends in these aspects of CHD over an eight year period and determined if ethnic differences existed.
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 13 May 2016.
- Background: PubMed 8508105Goff DC Jr, Varas C, Ramsey DJ, Wear ML, Labarthe DR, Nichaman MZ. Mortality after hospitalization for myocardial infarction among Mexican Americans and non-Hispanic whites: the Corpus Christi Heart Project. Ethn Dis. 1993 Winter;3(1):55-63.
- Background: PubMed 8013754Orlander PR, Goff DC, Morrissey M, Ramsey DJ, Wear ML, Labarthe DR, Nichaman MZ. The relation of diabetes to the severity of acute myocardial infarction and post-myocardial infarction survival in Mexican-Americans and non-Hispanic whites. The Corpus Christi Heart Project. Diabetes. 1994 Jul;43(7):897-902. doi: 10.2337/diab.43.7.897.
- Background: PubMed 8287155Nichaman MZ, Wear ML, Goff DC Jr, Labarthe DR. Hospitalization rates for myocardial infarction among Mexican-Americans and non-Hispanic whites. The Corpus Christi Heart Project. Ann Epidemiol. 1993 Jan;3(1):42-8. doi: 10.1016/1047-2797(93)90008-r.
- Background: PubMed 7606305Goff DC Jr, Nichaman MZ, Ramsey DJ, Meyer PS, Labarthe DR. A population-based assessment of the use and effectiveness of thrombolytic therapy. The Corpus Christi Heart Project. Ann Epidemiol. 1995 May;5(3):171-8. doi: 10.1016/1047-2797(94)00103-z.
- Background: PubMed 7794339Blumberg MS. Re: "Greater case-fatality after myocardial infarction among Mexican Americans and women than among non-Hispanic whites and men: The Corpus Christi Heart Project". Am J Epidemiol. 1995 Mar 1;141(5):478-80. doi: 10.1093/oxfordjournals.aje.a117453. No abstract available.
- BackgroundLabarthe DR: Changing Patterns in the Epidemiology of Coronary Artery Disease: Trends in Survival After Myocardial Infarction. In: Long-Term Management of Patients After Myocardial Infarction. Kappagoda CT, Greenwood PV, (Eds), Pages 17-30, 1987
- Background: PubMed 3807992Annegers JF, Hauser WA, Shirts SB, Kurland LT. Factors prognostic of unprovoked seizures after febrile convulsions. N Engl J Med. 1987 Feb 26;316(9):493-8. doi: 10.1056/NEJM198702263160901.
- Background: PubMed 3823009Slater CH, Green LW, Vernon SW, Keith VM. Problems in estimating the prevalence of physical activity from national surveys. Prev Med. 1987 Jan;16(1):107-18. doi: 10.1016/0091-7435(87)90010-7.
- BackgroundSlater CH, Carlton B, Ramirez G, Ashton C: Heart Disease, Strategies for Prevention. Eval Health Prof, 10(3):255-286, 1987
- Background: PubMed 8154471Goff DC Jr, Ramsey DJ, Labarthe DR, Nichaman MZ. Greater case-fatality after myocardial infarction among Mexican Americans and women than among non-Hispanic whites and men. The Corpus Christi Heart Project. Am J Epidemiol. 1994 Mar 1;139(5):474-83. doi: 10.1093/oxfordjournals.aje.a117030.
- Background: PubMed 8508106Goff DC Jr, Ramsey DJ, Labarthe DR, Nichaman MZ. Acute myocardial infarction and coronary heart disease mortality among Mexican Americans and non-Hispanic whites in Texas, 1980 through 1989. Ethn Dis. 1993 Winter;3(1):64-9.
- Background: PubMed 9118510Goff DC, Nichaman MZ, Chan W, Ramsey DJ, Labarthe DR, Ortiz C. Greater incidence of hospitalized myocardial infarction among Mexican Americans than non-Hispanic whites. The Corpus Christi Heart Project, 1988-1992. Circulation. 1997 Mar 18;95(6):1433-40. doi: 10.1161/01.cir.95.6.1433.
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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 Hypertension, 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 13 May 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 NCT00005198, which also lists 21 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 13 May 2016.