Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006420
Status:
COMPLETED
Last Update Posted:
2016-02-05
First Post:
2000-10-26
Brief Title:
Minnesota Heart Survey - Mortality and Morbidity
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Study of Trends of Cardiovascular Disease in a Metropolitan Area
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MHS
Brief Summary:
To continue surveillance of coronary heart disease CHD mortality and morbidity in the seven county metropolitan MinneapolisSt 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 MinneapolisSt Paul Twin Cities metropolitan area of Minnesota comprising a population of 23 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 MinneapolisSt 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
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 MinneapolisSt Paul Twin Cities metropolitan area of Minnesota comprising a population of 23 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 MinneapolisSt 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL065755 | NIH | None | httpsreporternihgovquickSearchR01HL065755 |