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Coronary Disease Morbidity and Mortality in a Population

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Veronique L. Roger, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00005502
First received: May 25, 2000
Last updated: May 13, 2013
Last verified: May 2013

May 25, 2000
May 13, 2013
October 2002
April 2013   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00005502 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
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 ]
Not Provided
 
Coronary Disease Morbidity and Mortality in a Population
Coronary Disease Morbidity and Mortality in a Population

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

plasma, serum and white blood cells are stored for future research projects

Probability Sample

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

  • Cardiovascular Diseases
  • Coronary Disease
  • Myocardial Infarction
  • Heart Diseases
Not Provided
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5476
April 2013
April 2013   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005502
632-01, R01HL059205
No
Veronique L. Roger, Mayo Clinic
Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Veronique Roger Mayo Foundation
Mayo Clinic
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP