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Coronary Disease Morbidity and Mortality in a Population

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005502
First Posted: May 26, 2000
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Veronique L. Roger, Mayo Clinic
  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 Veronique L. Roger, 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 ]

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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Heart, Lung, and Blood Institute (NHLBI)
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 ( U.S. NIH Grant/Contract )
First Submitted: May 25, 2000
First Posted: May 26, 2000
Last Update Posted: March 17, 2014
Last Verified: May 2013

Additional relevant MeSH terms:
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases