Minnesota Heart Survey - Mortality and Morbidity

NCT ID: NCT00006420

Last Updated: 2016-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2000-08-31

Study Completion Date

2006-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To continue surveillance of coronary heart disease (CHD) mortality and morbidity in the seven county metropolitan Minneapolis/St. Paul (Twin Cities) areas.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Infarction Death, Sudden, Cardiac

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Observational, no interventions

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

No eligibility criteria
Minimum Eligible Age

30 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Russell Luepker

Role:

University of Minnesota

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 14670826 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01HL065755

Identifier Type: NIH

Identifier Source: secondary_id

View Link

936

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evans County Studies
NCT00005122 COMPLETED