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
  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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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
Study Population

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

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005502

Locations
United States, Minnesota
St Marys Hospital
Rochester, Minnesota, United States, 55902
Rochester Methodist Hospital
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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 July 23, 2014