Cardiovascular DiseasesNCT00005196
Worcester Heart Attack Community Surveillance Study
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To examine time trends in the incidence rates of acute myocardial infarction and out-of-hospital coronary heart disease deaths as well as changes in the in-hospital and long-term case-fatality rates of acute myocardial infarction in the Worcester, Massachusetts Standard Metropolitan Statistical Area (SMSA). Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Dec 1986to Mar 2006
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To examine time trends in the incidence rates of acute myocardial infarction and out-of-hospital coronary heart disease deaths as well as changes in the in-hospital and long-term case-fatality rates of acute myocardial infarction in the Worcester, Massachusetts Standard Metropolitan Statistical Area (SMSA).
Read the detailed description
BACKGROUND:
Beginning in the 1920s, death rates from coronary heart disease in the United States rose in an unyielding fashion reaching epidemic proportions by the mid-1960s. Since that time, mortality attributed to coronary heart disease has leveled off and then turned markedly downwards. In the ten-year period between 1968 and 1978 there was a greater than 25 percent decline in the overall age-adjusted death rate from coronary heart disease, a phenomenon observed in both sexes, all age groups and in the three major race/ethnic groups. While this significant and encouraging decline appeared real and not due to artifactual changes in death certification practices, the causes of this decrease remain obscure and coronary heart disease continues as a major cause of death and disability in the United States. Internationally, inconsistent trends in mortality rates attributed to coronary heart disease have occurred. These rates declined from the early 1960s for Australia, Canada, France, Japan, Switzerland and Italy while mortality rates from coronary heart disease continued to increase from this period until the late 1970s for England and Wales, Ireland, Finland, Norway, New Zealand and Israel.
Despite this encouraging and enigmatic decline in mortality attributed to coronary heart disease in the United States and certain other countries, a paucity of population-based data exist to ascertain whether this temporal decline in death rates is due to changes in the incidence rates of new coronary events, changes in survival after an acute coronary episode or combinations thereof. These data are of crucial importance for formulating explanations for these declining mortality rates. A decline in the incidence rates of coronary heart disease would suggest that the mortality decline is due to measures of primary prevention and changes in the prevalence and/or levels of the major coronary risk factors such as, increased detection and control of hypertension, decreased cigarette smoking and declining serum cholesterol levels. If, however, the incidence rates of coronary heart disease are remaining steady or even increasing, a likely explanation of this downward trend in cardiovascular mortality would be that it is due to effort directed at secondary prevention including the establishment and more effective utilization of coronary care units, therapeutic interventions, and emergency medical services.
DESIGN NARRATIVE:
This longitudinal study examines recent (1997 and 1999) as compared to prior (1975, 1978, 1981, 1984, 1986, 1988, 1990, 1991, 1993, and 1995) time trends in the annual attack rates of acute myocardial infarction and out-of-hospital coronary heart disease deaths, recent (1997 and 1999) as well as prior (1975-1995) changes over time in the in-hospital and long-term survival rates of acute myocardial infarction, and the relationship of these incidence and survival patterns of acute myocardial infarction to selected demographic, clinical and medical care factors. The study also examines changes over time in the therapeutic management, diagnostic evaluation, and surgical workup of patients hospitalized with acute myocardial infarction, as well as related issues of cost.
The study was renewed in 1992 and again in 1997. The 1997 renewal study, carried out in 13 acute general hospitals in the Worcester Standard Metropolitan Statistical Area, used and extended previous approaches used in the conduct of the study. All new (incident) and recurrent episodes of definite acute myocardial infarction occurring among Worcester residents during calendar years 1997 and 1999 were identified from discharge diagnostic printouts obtained from all metropolitan Worcester hospitals. The medical records of these patients were individually reviewed for validation purposes according to pre-established diagnostic criteria for acute myocardial infarction. Abstraction of medical records of the patients satisfying the diagnostic and geographic eligibility criteria were carried out with the standardized recording of relevant data. A review of records for additional hospitalizations and a statewide and national search of death certificates were carried out to examine the long-term survival status of discharged hospital patients from each of the proposed study years as well as those identified previously (1975-1995) through the year 2000. Death certificates of Worcester SMSA residents were reviewed to identify cases of out-of-hospital deaths due to coronary heart disease occurring in 1997 and 1999 to determine temporal trends in these incidence rates.
The study was renewed in 2001 for five years to examine to examine recent (2000 and 2003) as compared to prior (1975 to 1999) trends in the annual attack and survival rates of AMI, out-of-hospital deaths attributed to CHD, and the relationship of these incidence and survival patterns of AMI to demographic, clinical, and medical care factors. An additional objective of this multi-hospital community-wide study is to examine changes over time in the use of selected therapies and coronary interventional approaches in patients hospitalized with AMI.
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, 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 startDec 1986
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (68)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
- Investigators
- Robert Goldberg, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005196
- Sponsor's protocol ID
- 1075
- Other IDs
- R01HL035434
- Status last verified
- May 2009
- First submitted
- 25 May 2000
- Last updated
- 29 Jul 2016
- Results posted
- No
Publications
Goldberg RJ, Gore JM, Alpert JS, Dalen JE. Recent changes in attack and survival rates of acute myocardial infarction (1975 through 1981). The Worcester Heart Attack Study. JAMA. 1986 May 23-30;255(20):2774-9.
PubMed 3701991Goldberg RJ, Gore JM, Alpert JS, Dalen JE. Therapeutic trends in the management of patients with acute myocardial infarction (1975-1984): the Worcester Heart Attack Study. Clin Cardiol. 1987 Jan;10(1):3-8. doi: 10.1002/clc.4960100103.
PubMed 2880685Goldberg RJ, Gore JM, Alpert JS, Dalen JE. Non-Q wave myocardial infarction: recent changes in occurrence and prognosis--a community-wide perspective. Am Heart J. 1987 Feb;113(2 Pt 1):273-9. doi: 10.1016/0002-8703(87)90265-1.
PubMed 3442573Goldberg RJ, Gore JM, Haffajee CI, Alpert JS, Dalen JE. Outcome after cardiac arrest during acute myocardial infarction. Am J Cardiol. 1987 Feb 1;59(4):251-5. doi: 10.1016/0002-9149(87)90794-6.
PubMed 3812274Goldberg RJ, Gore JM, Dalen JE. Current practice patterns in the management of acute myocardial infarction. Survey of the American College of Chest Physicians. Chest. 1987 Sep;92(3):550-4. doi: 10.1378/chest.92.3.550.
PubMed 3622035Gore JM, Goldberg RJ, Spodick DH, Alpert JS, Dalen JE. A community-wide assessment of the use of pulmonary artery catheters in patients with acute myocardial infarction. Chest. 1987 Oct;92(4):721-7. doi: 10.1378/chest.92.4.721.
PubMed 3652758Gore JM, Goldberg RJ, Alpert JS, Dalen JE. The increased use of diagnostic procedures in patients with acute myocardial infarction. A community-wide perspective. Arch Intern Med. 1987 Oct;147(10):1729-32.
PubMed 3116960Greene HL, Goldberg RJ, Ockene JK. Cigarette smoking: the physician's role in cessation and maintenance. J Gen Intern Med. 1988 Jan-Feb;3(1):75-87. doi: 10.1007/BF02595761. No abstract available.
PubMed 3276851Goldberg RJ, Gore JM, Alpert JS, Dalen JE. Incidence and case fatality rates of acute myocardial infarction (1975-1984): the Worcester Heart Attack Study. Am Heart J. 1988 Apr;115(4):761-7. doi: 10.1016/0002-8703(88)90876-9.
PubMed 3354404Goldberg RJ: Changing Prognosis of Acute Myocardial Infarction. Acute Coronary Care in the Thrombolytic Era. In: Year Book Medical Publisher's (Book Chapter), Califf R, Wagner G, Mark D, (Eds) p. 548-558, 1988
Goldberg RJ. A community-wide perspective of secular trends in the therapeutic management of patients with acute myocardial infarction. The Worcester Heart Attack Study. Cardiology. 1989;76(2):105-11. doi: 10.1159/000174481.
PubMed 2568178Gore JM, Goldberg RJ, Alpert JS, Dalen JE: Increased Use of Diagnostic Procedures in Patients with Acute Myocardial Infarction: The Worcester Heart Attack Study. In: Trends in Coronary Heart Disease Mortality. Luepker RV, Higgins MH (Eds). Oxford University Press, 1988.
Goldberg RJ, Gore JM, Gurwitz JH, Alpert JS, Brady P, Strohsnitter W, Chen ZY, Dalen JE. The impact of age on the incidence and prognosis of initial acute myocardial infarction: the Worcester Heart Attack Study. Am Heart J. 1989 Mar;117(3):543-9. doi: 10.1016/0002-8703(89)90727-8.
PubMed 2919534Goldberg RJ, Seeley D, Becker RC, Brady P, Chen ZY, Osganian V, Gore JM, Alpert JS, Dalen JE. Impact of atrial fibrillation on the in-hospital and long-term survival of patients with acute myocardial infarction: a community-wide perspective. Am Heart J. 1990 May;119(5):996-1001. doi: 10.1016/s0002-8703(05)80227-3.
PubMed 2330889Gurwitz JH, Goldberg RJ, Chen Z, Gore JM, Alpert JS. Beta-blocker therapy in acute myocardial infarction: evidence for underutilization in the elderly. Am J Med. 1992 Dec;93(6):605-10. doi: 10.1016/0002-9343(92)90192-e.
PubMed 1361302
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Worcester Heart Attack Community Surveillance Study
- ClinicalTrials.gov ID
- NCT00005196
- Acronym / sponsor ID
- 1075
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Dec 1986
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (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 examine time trends in the incidence rates of acute myocardial infarction and out-of-hospital coronary heart disease deaths as well as changes in the in-hospital and long-term case-fatality rates of acute myocardial infarction in the Worcester, Massachusetts Standard Metropolitan Statistical Area (SMSA).
Detailed description
BACKGROUND:
Beginning in the 1920s, death rates from coronary heart disease in the United States rose in an unyielding fashion reaching epidemic proportions by the mid-1960s. Since that time, mortality attributed to coronary heart disease has leveled off and then turned markedly downwards. In the ten-year period between 1968 and 1978 there was a greater than 25 percent decline in the overall age-adjusted death rate from coronary heart disease, a phenomenon observed in both sexes, all age groups and in the three major race/ethnic groups. While this significant and encouraging decline appeared real and not due to artifactual changes in death certification practices, the causes of this decrease remain obscure and coronary heart disease continues as a major cause of death and disability in the United States. Internationally, inconsistent trends in mortality rates attributed to coronary heart disease have occurred. These rates declined from the early 1960s for Australia, Canada, France, Japan, Switzerland and Italy while mortality rates from coronary heart disease continued to increase from this period until the late 1970s for England and Wales, Ireland, Finland, Norway, New Zealand and Israel.
Despite this encouraging and enigmatic decline in mortality attributed to coronary heart disease in the United States and certain other countries, a paucity of population-based data exist to ascertain whether this temporal decline in death rates is due to changes in the incidence rates of new coronary events, changes in survival after an acute coronary episode or combinations thereof. These data are of crucial importance for formulating explanations for these declining mortality rates. A decline in the incidence rates of coronary heart disease would suggest that the mortality decline is due to measures of primary prevention and changes in the prevalence and/or levels of the major coronary risk factors such as, increased detection and control of hypertension, decreased cigarette smoking and declining serum cholesterol levels. If, however, the incidence rates of coronary heart disease are remaining steady or even increasing, a likely explanation of this downward trend in cardiovascular mortality would be that it is due to effort directed at secondary prevention including the establishment and more effective utilization of coronary care units, therapeutic interventions, and emergency medical services.
DESIGN NARRATIVE:
This longitudinal study examines recent (1997 and 1999) as compared to prior (1975, 1978, 1981, 1984, 1986, 1988, 1990, 1991, 1993, and 1995) time trends in the annual attack rates of acute myocardial infarction and out-of-hospital coronary heart disease deaths, recent (1997 and 1999) as well as prior (1975-1995) changes over time in the in-hospital and long-term survival rates of acute myocardial infarction, and the relationship of these incidence and survival patterns of acute myocardial infarction to selected demographic, clinical and medical care factors. The study also examines changes over time in the therapeutic management, diagnostic evaluation, and surgical workup of patients hospitalized with acute myocardial infarction, as well as related issues of cost.
The study was renewed in 1992 and again in 1997. The 1997 renewal study, carried out in 13 acute general hospitals in the Worcester Standard Metropolitan Statistical Area, used and extended previous approaches used in the conduct of the study. All new (incident) and recurrent episodes of definite acute myocardial infarction occurring among Worcester residents during calendar years 1997 and 1999 were identified from discharge diagnostic printouts obtained from all metropolitan Worcester hospitals. The medical records of these patients were individually reviewed for validation purposes according to pre-established diagnostic criteria for acute myocardial infarction. Abstraction of medical records of the patients satisfying the diagnostic and geographic eligibility criteria were carried out with the standardized recording of relevant data. A review of records for additional hospitalizations and a statewide and national search of death certificates were carried out to examine the long-term survival status of discharged hospital patients from each of the proposed study years as well as those identified previously (1975-1995) through the year 2000. Death certificates of Worcester SMSA residents were reviewed to identify cases of out-of-hospital deaths due to coronary heart disease occurring in 1997 and 1999 to determine temporal trends in these incidence rates.
The study was renewed in 2001 for five years to examine to examine recent (2000 and 2003) as compared to prior (1975 to 1999) trends in the annual attack and survival rates of AMI, out-of-hospital deaths attributed to CHD, and the relationship of these incidence and survival patterns of AMI to demographic, clinical, and medical care factors. An additional objective of this multi-hospital community-wide study is to examine changes over time in the use of selected therapies and coronary interventional approaches in patients hospitalized with AMI.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- 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 29 Jul 2016.
- Background: PubMed 3701991Goldberg RJ, Gore JM, Alpert JS, Dalen JE. Recent changes in attack and survival rates of acute myocardial infarction (1975 through 1981). The Worcester Heart Attack Study. JAMA. 1986 May 23-30;255(20):2774-9.
- Background: PubMed 2880685Goldberg RJ, Gore JM, Alpert JS, Dalen JE. Therapeutic trends in the management of patients with acute myocardial infarction (1975-1984): the Worcester Heart Attack Study. Clin Cardiol. 1987 Jan;10(1):3-8. doi: 10.1002/clc.4960100103.
- Background: PubMed 3442573Goldberg RJ, Gore JM, Alpert JS, Dalen JE. Non-Q wave myocardial infarction: recent changes in occurrence and prognosis--a community-wide perspective. Am Heart J. 1987 Feb;113(2 Pt 1):273-9. doi: 10.1016/0002-8703(87)90265-1.
- Background: PubMed 3812274Goldberg RJ, Gore JM, Haffajee CI, Alpert JS, Dalen JE. Outcome after cardiac arrest during acute myocardial infarction. Am J Cardiol. 1987 Feb 1;59(4):251-5. doi: 10.1016/0002-9149(87)90794-6.
- Background: PubMed 3622035Goldberg RJ, Gore JM, Dalen JE. Current practice patterns in the management of acute myocardial infarction. Survey of the American College of Chest Physicians. Chest. 1987 Sep;92(3):550-4. doi: 10.1378/chest.92.3.550.
- Background: PubMed 3652758Gore JM, Goldberg RJ, Spodick DH, Alpert JS, Dalen JE. A community-wide assessment of the use of pulmonary artery catheters in patients with acute myocardial infarction. Chest. 1987 Oct;92(4):721-7. doi: 10.1378/chest.92.4.721.
- Background: PubMed 3116960Gore JM, Goldberg RJ, Alpert JS, Dalen JE. The increased use of diagnostic procedures in patients with acute myocardial infarction. A community-wide perspective. Arch Intern Med. 1987 Oct;147(10):1729-32.
- Background: PubMed 3276851Greene HL, Goldberg RJ, Ockene JK. Cigarette smoking: the physician's role in cessation and maintenance. J Gen Intern Med. 1988 Jan-Feb;3(1):75-87. doi: 10.1007/BF02595761. No abstract available.
- Background: PubMed 3354404Goldberg RJ, Gore JM, Alpert JS, Dalen JE. Incidence and case fatality rates of acute myocardial infarction (1975-1984): the Worcester Heart Attack Study. Am Heart J. 1988 Apr;115(4):761-7. doi: 10.1016/0002-8703(88)90876-9.
- BackgroundGoldberg RJ: Changing Prognosis of Acute Myocardial Infarction. Acute Coronary Care in the Thrombolytic Era. In: Year Book Medical Publisher's (Book Chapter), Califf R, Wagner G, Mark D, (Eds) p. 548-558, 1988
- Background: PubMed 2568178Goldberg RJ. A community-wide perspective of secular trends in the therapeutic management of patients with acute myocardial infarction. The Worcester Heart Attack Study. Cardiology. 1989;76(2):105-11. doi: 10.1159/000174481.
- BackgroundGore JM, Goldberg RJ, Alpert JS, Dalen JE: Increased Use of Diagnostic Procedures in Patients with Acute Myocardial Infarction: The Worcester Heart Attack Study. In: Trends in Coronary Heart Disease Mortality. Luepker RV, Higgins MH (Eds). Oxford University Press, 1988.
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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.
Robert Goldberg
University of Massachusetts, Worcester
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, 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 29 Jul 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 NCT00005196, which also lists 68 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 29 Jul 2016.