Cardiovascular DiseasesMHSNCT00005145
Minnesota Heart Survey - Risk Factor Survey
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Minnesota.
Trial summary
To continue surveillance of cardiovascular disease risk factors in the seven-county area of Minneapolis-St. Paul. Read more about this study
- Who is it for?
- Ages 8 to 84 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1979to Feb 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 84 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
Official title: Study of Trends in Cardiovascular Risk Factors in an Urban Population.
To continue surveillance of cardiovascular disease risk factors in the seven-county area of Minneapolis-St. Paul.
Read the detailed description
BACKGROUND:
Cardiovascular disease mortality rates, especially for myocardial infarction and stroke, have fallen markedly over the past several decades in all race, sex, and age groups in the United States. Between 1966 and 1986, the combined death rate for all cardiovascular diseases declined by 42 percent. In 1986, the death rate for coronary heart disease was 55 percent of what it had been in 1966, and cerebrovascular disease was 42 percent of what it had been in 1966. The decline is assumed to be related to several factors including improved medical care and risk factor modification for elevated blood lipids, cigarette smoking, and hypertension. The Minnesota Heart Survey provide trends (1970-2002) in coronary heart disease deaths out-of-hospital, in hospitalization rates, case fatality and survivorship for myocardial infarction and stroke in the metropolitan area.
DESIGN NARRATIVE:
Between 1979 and 1999, R01HL23727 supported mortality surveillance and morbidity surveillance. Beginning in FY 2000, R01HL65755 supports the morbidity and mortality surveillance and R01HL23727 supports the risk factor survey.
Mortality Surveillance: The mortality surveillance was a continuation of a surveillance study performed by the investigators since 1960 for the state of Minnesota. Mortality data for hypertension, stroke, coronary heart disease, and all cardiovascular renal disease were monitored for the Twin City metropolitan area with a total population of two million. Age, sex, area, location of death and cause-specific death rates were followed. Trends in cancer, diabetes, and other non-cardiovascular disease were examined. Case fatality rates, including one- and five-year survivorships were determined and related to coronary heart disease mortality trends.
Morbidity Surveillance: All discharges from the seven-county area hospitals with acute and chronic myocardial heart disease and stroke listed among the discharge diagnoses were recorded using Professional Standards Review Organization data tapes. A ten percent random sample of all recorded diagnoses were validated yearly by abstracting data from hospital records. Each year's validation sample of definite and probable cases of myocardial infarction and stroke formed a cohort to be followed for mortality for one year after the onset of the disease event. Individual hospitals and the Professional Standards Review Organization in the area provided data on the total numbers of coronary care unit admissions and coronary artery bypass operations for each year. Beginning in August 1988, a registry was established for all new incident cases of coronary heart disease at the University of Minnesota Hospital and the Ramsey County Hospital. In 1989, twelve hospitals were part of the myocardial infarction registry.
Risk Factor Surveillance: Population samples, aged 25-74 years, are recruited and measured for blood pressure, serum cholesterol, serum high density lipoprotein cholesterol, cigarette smoking, diet, physical activity, height, weight, health attitudes and beliefs, and coronary prone behavior. Surveys were completed in 1980-1982 and 1984-1985. The third survey conducted in 1990-1992 included the Willett Food Frequency Questionnaire and bioimpedance measurements. A nested case-control study using the 1980-1982 risk factor cohort examined the baseline cardiovascular disease risk factor differences between coronary heart disease in cases and controls.
The study was renewed in the year 2000 under R01HL23727 to conduct a population survey of 4,000 adults, ages 25 to 84 in 2000-2002, to detect current trends in cardiovascular disease risk factors, including serum lipids, blood pressure, cigarette smoking prevalence, dietary fat intake, obesity, diabetes, physical inactivity, fibrinogen, and serum vitamin E. Cohort and ecological analyses will be used to link secular trends in risk factors to morbidity and mortality from coronary heart disease, congestive heart failure, and stroke. A total of 1,000 children and adolescents, ages 8-17, will also be surveyed using youth-specific measurement instruments where appropriate.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident, Coronary Disease, Hypertension, Myocardial Infarction
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Stroke, Coronary Disease, Hypertension, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational, no interventions | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular risk factor trends
Measured: 26 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startApr 1979
- Primary completionFeb 2005
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (82)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Donna Arnett, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005145
- Sponsor's protocol ID
- 1016
- Other IDs
- R01HL023727
- Acronym
- MHS
- Status last verified
- Feb 2016
- First submitted
- 25 May 2000
- Last updated
- 5 Feb 2016
- Results posted
- No
Publications
Luepker RV, Rastam L, Hannan PJ, Murray DM, Gray C, Baker WL, Crow R, Jacobs DR Jr, Pirie PL, Mascioli SR, Mittelmark MB, Blackburn H. Community education for cardiovascular disease prevention. Morbidity and mortality results from the Minnesota Heart Health Program. Am J Epidemiol. 1996 Aug 15;144(4):351-62. doi: 10.1093/oxfordjournals.aje.a008936.
PubMed 8712192Rosamond WD, Shahar E, Luepker RV. Assessing medical history in coronary heart disease surveillance: agreement between contemporaneous and retrospective methods. Epidemiology. 1996 Jul;7(4):447-9. doi: 10.1097/00001648-199607000-00020.
PubMed 8793376Pieper RM, Arnett DK, McGovern PG, Shahar E, Blackburn H, Luepker RV. Trends in cholesterol knowledge and screening and hypercholesterolemia awareness and treatment, 1980-1992. The Minnesota Heart Survey. Arch Intern Med. 1997 Nov 10;157(20):2326-32.
PubMed 9361573McGovern PG, Herlitz J, Pankow JS, Karlsson T, Dellborg M, Shahar E, Luepker RV. Comparison of medical care and one- and 12-month mortality of hospitalized patients with acute myocardial infarction in Minneapolis-St. Paul, Minnesota, United States of America and Goteborg, Sweden. Am J Cardiol. 1997 Sep 1;80(5):557-62. doi: 10.1016/s0002-9149(97)00421-9.
PubMed 9294981Iribarren C, Luepker RV, McGovern PG, Arnett DK, Blackburn H. Twelve-year trends in cardiovascular disease risk factors in the Minnesota Heart Survey. Are socioeconomic differences widening? Arch Intern Med. 1997 Apr 28;157(8):873-81.
PubMed 9129547Shahar E, Lewis M, Keil U, McGovern PG, Lowel H, Luepker RV. Hospital care and survival of acute myocardial infarction patients in Minnesota and southern Germany: a comparative study. Coron Artery Dis. 1996 Jun;7(6):467-73. doi: 10.1097/00019501-199606000-00010.
PubMed 8889363Venters MH, Jacobs DR Jr, Luepker RV, Maiman LA, Gillum RF. Spouse concordance of smoking patterns: the Minnesota Heart Survey. Am J Epidemiol. 1984 Oct;120(4):608-16. doi: 10.1093/oxfordjournals.aje.a113922.
PubMed 6475929Gillum RF, Liu KC. Coronary heart disease mortality in United States blacks, 1940-1978: trends and unanswered questions. Am Heart J. 1984 Sep;108(3 Pt 2):728-32. doi: 10.1016/0002-8703(84)90665-3. No abstract available.
PubMed 6475741Folsom AR, Prineas RJ, Jacobs DR, Luepker RV, Gillum RF. Measured differences between fourth and fifth phase diastolic blood pressures in 4885 adults: implications for blood pressure surveys. Int J Epidemiol. 1984 Dec;13(4):436-41. doi: 10.1093/ije/13.4.436.
PubMed 6519881Folsom AR, Caspersen CJ, Taylor HL, Jacobs DR Jr, Luepker RV, Gomez-Marin O, Gillum RF, Blackburn H. Leisure time physical activity and its relationship to coronary risk factors in a population-based sample. The Minnesota Heart Survey. Am J Epidemiol. 1985 Apr;121(4):570-9. doi: 10.1093/oxfordjournals.aje.a114035.
PubMed 4014146Gillum RF, Gomez-Marin O, Kottke TE, Jacobs DR Jr, Prineas RJ, Folsom AR, Luepker RV, Blackburn H. Acute stroke in a metropolitan area, 1970 and 1980. The Minnesota Heart Survey. J Chronic Dis. 1985;38(11):891-8. doi: 10.1016/0021-9681(85)90124-9.
PubMed 4055977Luepker RV, Jacobs DR, Gillum RF, Folsom AR, Prineas RJ, Blackburn H. Population risk of cardiovascular disease: the Minnesota Heart Survey. J Chronic Dis. 1985;38(8):671-82. doi: 10.1016/0021-9681(85)90021-9.
PubMed 4019704Pechacek TF, Folsom AR, de Gaudermaris R, Jacobs DR Jr, Luepker RV, Gillum RF, Blackburn H. Smoke exposure in pipe and cigar smokers. Serum thiocyanate measures. JAMA. 1985 Dec 20;254(23):3330-2.
PubMed 4068167Sorensen G, Pirie P, Folsom A, Luepker R, Jacobs D, Gillum R. Sex differences in the relationship between work and health: the Minnesota Heart Survey. J Health Soc Behav. 1985 Dec;26(4):379-94. No abstract available.
PubMed 4086760Folsom AR, Smith CL, Prineas RJ, Grimm RH Jr. Serum calcium fractions in essential hypertensive and matched normotensive subjects. Hypertension. 1986 Jan;8(1):11-5. doi: 10.1161/01.hyp.8.1.11.
PubMed 3943882
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Trends in Cardiovascular Risk Factors in an Urban Population.
- ClinicalTrials.gov ID
- NCT00005145
- Acronym / sponsor ID
- MHS / 1016
- Conditions
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident, Coronary Disease, Hypertension, Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 1979
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To continue surveillance of cardiovascular disease risk factors in the seven-county area of Minneapolis-St. Paul.
Detailed description
BACKGROUND:
Cardiovascular disease mortality rates, especially for myocardial infarction and stroke, have fallen markedly over the past several decades in all race, sex, and age groups in the United States. Between 1966 and 1986, the combined death rate for all cardiovascular diseases declined by 42 percent. In 1986, the death rate for coronary heart disease was 55 percent of what it had been in 1966, and cerebrovascular disease was 42 percent of what it had been in 1966. The decline is assumed to be related to several factors including improved medical care and risk factor modification for elevated blood lipids, cigarette smoking, and hypertension. The Minnesota Heart Survey provide trends (1970-2002) in coronary heart disease deaths out-of-hospital, in hospitalization rates, case fatality and survivorship for myocardial infarction and stroke in the metropolitan area.
DESIGN NARRATIVE:
Between 1979 and 1999, R01HL23727 supported mortality surveillance and morbidity surveillance. Beginning in FY 2000, R01HL65755 supports the morbidity and mortality surveillance and R01HL23727 supports the risk factor survey.
Mortality Surveillance: The mortality surveillance was a continuation of a surveillance study performed by the investigators since 1960 for the state of Minnesota. Mortality data for hypertension, stroke, coronary heart disease, and all cardiovascular renal disease were monitored for the Twin City metropolitan area with a total population of two million. Age, sex, area, location of death and cause-specific death rates were followed. Trends in cancer, diabetes, and other non-cardiovascular disease were examined. Case fatality rates, including one- and five-year survivorships were determined and related to coronary heart disease mortality trends.
Morbidity Surveillance: All discharges from the seven-county area hospitals with acute and chronic myocardial heart disease and stroke listed among the discharge diagnoses were recorded using Professional Standards Review Organization data tapes. A ten percent random sample of all recorded diagnoses were validated yearly by abstracting data from hospital records. Each year's validation sample of definite and probable cases of myocardial infarction and stroke formed a cohort to be followed for mortality for one year after the onset of the disease event. Individual hospitals and the Professional Standards Review Organization in the area provided data on the total numbers of coronary care unit admissions and coronary artery bypass operations for each year. Beginning in August 1988, a registry was established for all new incident cases of coronary heart disease at the University of Minnesota Hospital and the Ramsey County Hospital. In 1989, twelve hospitals were part of the myocardial infarction registry.
Risk Factor Surveillance: Population samples, aged 25-74 years, are recruited and measured for blood pressure, serum cholesterol, serum high density lipoprotein cholesterol, cigarette smoking, diet, physical activity, height, weight, health attitudes and beliefs, and coronary prone behavior. Surveys were completed in 1980-1982 and 1984-1985. The third survey conducted in 1990-1992 included the Willett Food Frequency Questionnaire and bioimpedance measurements. A nested case-control study using the 1980-1982 risk factor cohort examined the baseline cardiovascular disease risk factor differences between coronary heart disease in cases and controls.
The study was renewed in the year 2000 under R01HL23727 to conduct a population survey of 4,000 adults, ages 25 to 84 in 2000-2002, to detect current trends in cardiovascular disease risk factors, including serum lipids, blood pressure, cigarette smoking prevalence, dietary fat intake, obesity, diabetes, physical inactivity, fibrinogen, and serum vitamin E. Cohort and ecological analyses will be used to link secular trends in risk factors to morbidity and mortality from coronary heart disease, congestive heart failure, and stroke. A total of 1,000 children and adolescents, ages 8-17, will also be surveyed using youth-specific measurement instruments where appropriate.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational, no interventions | – | – |
Who may qualify
- Ages
- 8 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular risk factor trends
Time frame: 26 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
- Background: PubMed 8712192Luepker RV, Rastam L, Hannan PJ, Murray DM, Gray C, Baker WL, Crow R, Jacobs DR Jr, Pirie PL, Mascioli SR, Mittelmark MB, Blackburn H. Community education for cardiovascular disease prevention. Morbidity and mortality results from the Minnesota Heart Health Program. Am J Epidemiol. 1996 Aug 15;144(4):351-62. doi: 10.1093/oxfordjournals.aje.a008936.
- Background: PubMed 8793376Rosamond WD, Shahar E, Luepker RV. Assessing medical history in coronary heart disease surveillance: agreement between contemporaneous and retrospective methods. Epidemiology. 1996 Jul;7(4):447-9. doi: 10.1097/00001648-199607000-00020.
- Background: PubMed 9361573Pieper RM, Arnett DK, McGovern PG, Shahar E, Blackburn H, Luepker RV. Trends in cholesterol knowledge and screening and hypercholesterolemia awareness and treatment, 1980-1992. The Minnesota Heart Survey. Arch Intern Med. 1997 Nov 10;157(20):2326-32.
- Background: PubMed 9294981McGovern PG, Herlitz J, Pankow JS, Karlsson T, Dellborg M, Shahar E, Luepker RV. Comparison of medical care and one- and 12-month mortality of hospitalized patients with acute myocardial infarction in Minneapolis-St. Paul, Minnesota, United States of America and Goteborg, Sweden. Am J Cardiol. 1997 Sep 1;80(5):557-62. doi: 10.1016/s0002-9149(97)00421-9.
- Background: PubMed 9129547Iribarren C, Luepker RV, McGovern PG, Arnett DK, Blackburn H. Twelve-year trends in cardiovascular disease risk factors in the Minnesota Heart Survey. Are socioeconomic differences widening? Arch Intern Med. 1997 Apr 28;157(8):873-81.
- Background: PubMed 8889363Shahar E, Lewis M, Keil U, McGovern PG, Lowel H, Luepker RV. Hospital care and survival of acute myocardial infarction patients in Minnesota and southern Germany: a comparative study. Coron Artery Dis. 1996 Jun;7(6):467-73. doi: 10.1097/00019501-199606000-00010.
- Background: PubMed 6475929Venters MH, Jacobs DR Jr, Luepker RV, Maiman LA, Gillum RF. Spouse concordance of smoking patterns: the Minnesota Heart Survey. Am J Epidemiol. 1984 Oct;120(4):608-16. doi: 10.1093/oxfordjournals.aje.a113922.
- Background: PubMed 6475741Gillum RF, Liu KC. Coronary heart disease mortality in United States blacks, 1940-1978: trends and unanswered questions. Am Heart J. 1984 Sep;108(3 Pt 2):728-32. doi: 10.1016/0002-8703(84)90665-3. No abstract available.
- Background: PubMed 6519881Folsom AR, Prineas RJ, Jacobs DR, Luepker RV, Gillum RF. Measured differences between fourth and fifth phase diastolic blood pressures in 4885 adults: implications for blood pressure surveys. Int J Epidemiol. 1984 Dec;13(4):436-41. doi: 10.1093/ije/13.4.436.
- Background: PubMed 4014146Folsom AR, Caspersen CJ, Taylor HL, Jacobs DR Jr, Luepker RV, Gomez-Marin O, Gillum RF, Blackburn H. Leisure time physical activity and its relationship to coronary risk factors in a population-based sample. The Minnesota Heart Survey. Am J Epidemiol. 1985 Apr;121(4):570-9. doi: 10.1093/oxfordjournals.aje.a114035.
- Background: PubMed 4055977Gillum RF, Gomez-Marin O, Kottke TE, Jacobs DR Jr, Prineas RJ, Folsom AR, Luepker RV, Blackburn H. Acute stroke in a metropolitan area, 1970 and 1980. The Minnesota Heart Survey. J Chronic Dis. 1985;38(11):891-8. doi: 10.1016/0021-9681(85)90124-9.
- Background: PubMed 4019704Luepker RV, Jacobs DR, Gillum RF, Folsom AR, Prineas RJ, Blackburn H. Population risk of cardiovascular disease: the Minnesota Heart Survey. J Chronic Dis. 1985;38(8):671-82. doi: 10.1016/0021-9681(85)90021-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Arnett
University of Minnesota
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular risk factor trends (time frame: 26 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005145, which also lists 82 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2016.