Coronary Disease Morbidity and Mortality in a Population

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00005502
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
5,476
2
126
2738
21.7

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    5476 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Coronary Disease Morbidity and Mortality in a Population
    Study Start Date :
    Oct 1, 2002
    Actual Primary Completion Date :
    Apr 1, 2013
    Actual Study Completion Date :
    Apr 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. To measure the number of Olmsted County,MN residents who have a Myocardial Infarction and Unstable Angina. [1979 through 2012]

    Secondary Outcome Measures

    1. To measure the survival of Olmsted County, MN residents after having a Myocardial Infarction or Unstable Angina event [1979-2012]

    Other Outcome Measures

    1. To examine the value of biomarkers on prediction of risks in Olmsted County, MN residents who have a Myocardial Infarction or Unstable Angina [2002-2012]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    All residents of Olmsted County, MN who are hospitalized and have an elevated Troponin level.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St Marys Hospital Rochester Minnesota United States 55902
    2 Rochester Methodist Hospital Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic
    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • Principal Investigator: Veronique Roger, Mayo Foundation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Veronique L. Roger, Consultant- Cardiology NonInvasive, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT00005502
    Other Study ID Numbers:
    • 632-01
    • R01HL059205
    First Posted:
    May 26, 2000
    Last Update Posted:
    May 14, 2013
    Last Verified:
    May 1, 2013

    Study Results

    No Results Posted as of May 14, 2013