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Minnesota Heart Survey - Mortality and Morbidity (MHS)

Primary Purpose

Cardiovascular Diseases, Coronary Disease, Heart Diseases

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

30 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Arm Label

    Observational, no interventions

    Arm Description

    Outcomes

    Primary Outcome Measures

    Cardiovascular, morbidity and mortality

    Secondary Outcome Measures

    Full Information

    First Posted
    October 26, 2000
    Last Updated
    February 3, 2016
    Sponsor
    University of Minnesota
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00006420
    Brief Title
    Minnesota Heart Survey - Mortality and Morbidity
    Acronym
    MHS
    Official Title
    Study of Trends of Cardiovascular Disease in a Metropolitan Area.
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2000 (undefined)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    June 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Minnesota
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To continue surveillance of coronary heart disease (CHD) mortality and morbidity in the seven county metropolitan Minneapolis/St. Paul (Twin Cities) areas.
    Detailed Description
    BACKGROUND: The Minnesota Heart Survey (MHS) is among the few population-based longitudinal studies to monitor and explain trends in coronary heart disease (CHD) mortality and morbidity, the leading cause of death and disability in the United States. It encompasses a large and well-defined community, the Minneapolis/St. Paul (Twin Cities) metropolitan area of Minnesota, comprising a population of 2.3 million (1990 census) For almost two decade the Minnesota Heart Survey has made contributions to understanding 1) the components of the decline of coronary heart disease mortality including incidence rate, hospitalized attach rate, case fatality, and population levels of CHD risk factors; and 2) the methodology of disease surveillance in a time when classification and diagnostic technologies are constantly changing. DESIGN NARRATIVE: The Minnesota Heart Survey continues surveillance of coronary heart disease (CHD) mortality and morbidity in the seven county metropolitan Minneapolis/St. Paul (Twin Cities) areas through the year 2002. The study will also monitor trends in acute myocardial infarction (AMI), evaluate the effect on AMI diagnosis of the widespread use of new biomarkers (troponins), perform a validation study to the previous standard, and evaluate out-of-hospital sudden cardiac death (SCD) through an autopsy study A combination of different techniques will be used for surveillance. CHD deaths will be obtained from death certificate data from the Minneapolis Department of Public Health. Census data will be used to construct the appropriate denominators. A major focus is based on in-hospital CHD morbidity and mortality. Data from the Minnesota Hospital and Health Care Partnership, which originally receives data from 22 of the 23 area hospitals, will be used to identify and validate acute myocardial infarction (AMI) cases. Census data will again be used to obtain the appropriate denominators. An important issue in assessing time trends in hospitalized AMI attack rate is the changing definitions used to identify cases over time. A specific issue in this regard is the increasing use of troponin levels that are more sensitive than previously used CKMB levels to identify cases. Thus, a validation study will be conducted comparing these two methodologies on the same subjects. The goal of the study is to obtain correction factors so that time trends in AMI attack rates are not influenced by differences in diagnostic criteria. A new important area of investigation is that of out of-hospital sudden cardiac deaths (SCD). Autopsy studies of 100 cases per year (about 300 total) will be conducted to describe risk factors for SCD. In addition, comparisons will be made between a control group of 600 persons in the risk factor study. .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Death, Sudden, Cardiac

    7. Study Design

    8. Arms, Groups, and Interventions

    Arm Title
    Observational, no interventions
    Primary Outcome Measure Information:
    Title
    Cardiovascular, morbidity and mortality

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    84 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Russell Luepker
    Organizational Affiliation
    University of Minnesota

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    14670826
    Citation
    Lin JC, Apple FS, Murakami MM, Luepker RV. Rates of positive cardiac troponin I and creatine kinase MB mass among patients hospitalized for suspected acute coronary syndromes. Clin Chem. 2004 Feb;50(2):333-8. doi: 10.1373/clinchem.2003.026708. Epub 2003 Dec 11.
    Results Reference
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    Minnesota Heart Survey - Mortality and Morbidity

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