Coronary Disease Morbidity and Mortality in a Population
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Purpose
To study the entire population of Olmsted County, Minnesota, including all age categories, to examine the secular trends in coronary heart disease (CHD) mortality, myocardial infarction (MI) incidence, and natural history, including MI severity, case fatality and post-MI morbidity. Also, to examine the time trends in the prevalence of CHD at post-mortem because of the uniquely high autopsy rate in Olmsted County.
| Condition |
|---|
|
Cardiovascular Diseases Coronary Disease Myocardial Infarction Heart Diseases |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Coronary Disease Morbidity and Mortality in a Population |
- To measure the number of Olmsted County,MN residents who have a Myocardial Infarction and Unstable Angina. [ Time Frame: 1979 through 2012 ] [ Designated as safety issue: No ]
- To measure the survival of Olmsted County, MN residents after having a Myocardial Infarction or Unstable Angina event [ Time Frame: 1979-2012 ] [ Designated as safety issue: No ]
- To examine the value of biomarkers on prediction of risks in Olmsted County, MN residents who have a Myocardial Infarction or Unstable Angina [ Time Frame: 2002-2012 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
plasma, serum and white blood cells are stored for future research projects
| Enrollment: | 5476 |
| Study Start Date: | October 2002 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Residents of Olmsted County, MN with elevated Troponins
Anyone admitted to St Marys or Rochester Methodist Hospitals who have an elevated troponin during their hospitalization and are residents of Olmsted County, MN
|
Detailed Description:
BACKGROUND:
Cardiovascular disease remains the leading cause of death in the U.S. Despite an encouraging decline in age-adjusted coronary heart disease (CHD) mortality, prevalent CHD continues to represent a major health burden, particularly in the elderly population. Most community surveillance programs, however, cannot fully characterize this problem because they are restricted to an upper age limit of 74 years and thus do not include the events occurring in an increasingly growing part of the population. Observational studies have questioned the existence of a change over time in the prevalence of anatomic coronary disease either at post-mortem examination or at coronary angiography. This remains to be further examined in a population-based setting. In addition, the natural history of myocardial infarction (MI) in the reperfusion area is unknown; in particular, there are no population-based data on the incidence of post-MI heart failure.
DESIGN NARRATIVE:
The records of all Olmsted County residents with a hospital discharge diagnosis of MI between 1979 and 1999 were reviewed, and standard epidemiologic MI validation criteria were applied; post-MI outcome over time was determined, including post-MI heart failure, angina, 30 day case fatality and long-term survival. In parallel with the analysis of time trends in CHD mortality, the autopsy reports were reviewed to examine whether the prevalence of coronary disease at autopsy has changed over time. These studies provided an assessment of the clinical and anatomical manifestations of CHD, including the outcome of acute MI, over a time period characterized by intensified primary prevention efforts and major changes in the treatment of acute CHD.
The study was renewed in July 2002 to continue surveillance of acute coronary heart disease events in order to address issues surrounding the diagnostic precision and risk stratification potential of troponin and high sensitivity C reactive protein (CRP) and to monitor secular trends in severity and treatment modalities. Novel approaches to the procurement of carefully timed blood samples allow direct measurement of the increase in number of cases of myocardial infarction using the new biomarker, troponin. An examination will be made of the prognostic value of quantitative peak troponin measured at 24 to 36 hours and high sensitivity C reactive protein measured early after symptom onset in the myocardial infarction cohort.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
All residents of Olmsted County, MN who are hospitalized and have an elevated Troponin level.Non-residenst of Olmsted County are excluded.
All residents of Olmsted County, MN who are hospitalized and have an elevated Troponin level.
Contacts and Locations| United States, Minnesota | |
| St Marys Hospital | |
| Rochester, Minnesota, United States, 55902 | |
| Rochester Methodist Hospital | |
| Rochester, Minnesota, United States, 55905 | |
| Principal Investigator: | Veronique Roger | Mayo Foundation |
More Information
Publications:
| Responsible Party: | Veronique L. Roger, Consultant- Cardiology NonInvasive, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00005502 History of Changes |
| Other Study ID Numbers: | 632-01, R01HL059205 |
| Study First Received: | May 25, 2000 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Coronary Disease Coronary Artery Disease Heart Diseases Infarction Myocardial Infarction Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Ischemia Pathologic Processes Necrosis |
ClinicalTrials.gov processed this record on May 19, 2013