Cardiovascular DiseasesNCT00005156
Mortality Surveillance of MRFIT Screenees
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Minnesota.
Trial summary
To ascertain the sixteen year mortality status of the 361,662 middle-aged men screened in 1973-1975 for the Multiple Risk Factor Intervention Trial (MRFIT). Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1982to Jul 1996
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To ascertain the sixteen year mortality status of the 361,662 middle-aged men screened in 1973-1975 for the Multiple Risk Factor Intervention Trial (MRFIT).
Read the detailed description
BACKGROUND:
The Multiple Risk Factor Intervention Trial was a randomized primary prevention trial to test the effect of a multifactor intervention program on mortality from coronary heart disease in 12,866 high-risk men aged 35 to 57. The primary screening for MRFIT began in November 1973 and continued through November 1, 1975. The primary screening was conducted at clinical center sites, central neighborhood locations, and places of employment. Information was collected on smoking history, blood pressure, serum cholesterol, birthdate, race, and social security number as well as previous hospitalization for a heart attack and use of medication for diabetes. Systolic and diastolic blood pressures were measured and blood drawn for serum cholesterol determinations. The results of the screening examination were transmitted to the Coordinating Center.
DESIGN NARRATIVE:
Using data supplied by the Social Security Administration, the vital status of the MRFIT screenees was determined. A screenee was identified as deceased if the social security number and first two letters of the last name, as recorded on the MRFIT screening form, matched a record on the Social Security Administration master death file. The state health department was contacted to obtain the death certificate which was then coded for the underlying cause of death according to the International Classification of Diseases, 9th Revision. Because the Social Security Adminstration master death file was not completely accurate, the National Death Index was also used. Studies were conducted on the relationships of isolated systolic hypertension to stroke and coronary heart disease mortality, and on seasonal and regional variations in cardiovascular mortality. Using data from the Census Bureau (education and income levels by zip code), the socio-economic status of participants was indirectly estimated and the coronary heart disease and cancer death rate differences between white and Black men were evaluated by social class. Studies were also conducted on the associations of cause- specific cancer mortality and serum cholesterol concentration, and on the association of serum cholesterol, diastolic blood pressure, and cigarettes smoked per day with mortality from coronary heart disease and cerebrovascular disease for Black and white men.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident, Coronary Disease, Hypertension, Cardiomyopathy, Congestive
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Stroke, Coronary Disease, Hypertension, Cardiomyopathy, Dilated
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 1982
- Study completionJul 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)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)
- Investigators
- James Neaton, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005156
- Sponsor's protocol ID
- 1028
- Other IDs
- R01HL028715
- Status last verified
- Feb 2016
- First submitted
- 25 May 2000
- Last updated
- 1 Mar 2016
- Results posted
- No
Publications
Wentworth DN, Neaton JD, Rasmussen WL. An evaluation of the Social Security Administration master beneficiary record file and the National Death Index in the ascertainment of vital status. Am J Public Health. 1983 Nov;73(11):1270-4. doi: 10.2105/ajph.73.11.1270.
PubMed 6625030Neaton JD, Kuller LH, Wentworth D, Borhani NO. Total and cardiovascular mortality in relation to cigarette smoking, serum cholesterol concentration, and diastolic blood pressure among black and white males followed up for five years. Am Heart J. 1984 Sep;108(3 Pt 2):759-69. doi: 10.1016/0002-8703(84)90669-0.
PubMed 6475745Stamler J, Wentworth D, Neaton JD. Prevalence and prognostic significance of hypercholesterolemia in men with hypertension. Prospective data on the primary screenees of the Multiple Risk Factor Intervention Trial. Am J Med. 1986 Feb 14;80(2A):33-9. doi: 10.1016/0002-9343(86)90158-0.
PubMed 3946459Sherwin RW, Wentworth DN, Cutler JA, Hulley SB, Kuller LH, Stamler J. Serum cholesterol levels and cancer mortality in 361,662 men screened for the Multiple Risk Factor Intervention Trial. JAMA. 1987 Feb 20;257(7):943-8.
PubMed 3806876Stamler J, Wentworth D, Neaton JD. Is relationship between serum cholesterol and risk of premature death from coronary heart disease continuous and graded? Findings in 356,222 primary screenees of the Multiple Risk Factor Intervention Trial (MRFIT). JAMA. 1986 Nov 28;256(20):2823-8.
PubMed 3773199Martin MJ, Hulley SB, Browner WS, Kuller LH, Wentworth D. Serum cholesterol, blood pressure, and mortality: implications from a cohort of 361,662 men. Lancet. 1986 Oct 25;2(8513):933-6. doi: 10.1016/s0140-6736(86)90597-0.
PubMed 2877128Kannel WB, Neaton JD, Wentworth D, Thomas HE, Stamler J, Hulley SB, Kjelsberg MO. Overall and coronary heart disease mortality rates in relation to major risk factors in 325,348 men screened for the MRFIT. Multiple Risk Factor Intervention Trial. Am Heart J. 1986 Oct;112(4):825-36. doi: 10.1016/0002-8703(86)90481-3.
PubMed 3532744Rutan GH, Kuller LH, Neaton JD, Wentworth DN, McDonald RH, Smith WM. Mortality associated with diastolic hypertension and isolated systolic hypertension among men screened for the Multiple Risk Factor Intervention Trial. Circulation. 1988 Mar;77(3):504-14. doi: 10.1161/01.cir.77.3.504.
PubMed 3277736Iso H, Jacobs DR Jr, Wentworth D, Neaton JD, Cohen JD. Serum cholesterol levels and six-year mortality from stroke in 350,977 men screened for the multiple risk factor intervention trial. N Engl J Med. 1989 Apr 6;320(14):904-10. doi: 10.1056/NEJM198904063201405.
PubMed 2619783Neaton JD, Blackburn H, Jacobs D, Kuller L, Lee DJ, Sherwin R, Shih J, Stamler J, Wentworth D. Serum cholesterol level and mortality findings for men screened in the Multiple Risk Factor Intervention Trial. Multiple Risk Factor Intervention Trial Research Group. Arch Intern Med. 1992 Jul;152(7):1490-500.
PubMed 1627030Neaton JD, Wentworth D. Serum cholesterol, blood pressure, cigarette smoking, and death from coronary heart disease. Overall findings and differences by age for 316,099 white men. Multiple Risk Factor Intervention Trial Research Group. Arch Intern Med. 1992 Jan;152(1):56-64.
PubMed 1728930Neaton JD, Duchene AG, Svendsen KH, Wentworth D. An examination of the efficiency of some quality assurance methods commonly employed in clinical trials. Stat Med. 1990 Jan-Feb;9(1-2):115-23; discussion 124. doi: 10.1002/sim.4780090118.
PubMed 2345830Klag MJ, Whelton PK, Randall BL, Neaton JD, Brancati FL, Ford CE, Shulman NB, Stamler J. Blood pressure and end-stage renal disease in men. N Engl J Med. 1996 Jan 4;334(1):13-8. doi: 10.1056/NEJM199601043340103.
PubMed 7494564Neaton JD, Wentworth DN, Cutler J, Stamler J, Kuller L. Risk factors for death from different types of stroke. Multiple Risk Factor Intervention Trial Research Group. Ann Epidemiol. 1993 Sep;3(5):493-9. doi: 10.1016/1047-2797(93)90103-b.
PubMed 8167825Coughlin SS, Neaton JD, Sengupta A, Kuller LH. Predictors of mortality from idiopathic dilated cardiomyopathy in 356,222 men screened for the Multiple Risk Factor Intervention Trial. Am J Epidemiol. 1994 Jan 15;139(2):166-72. doi: 10.1093/oxfordjournals.aje.a116978.
PubMed 8296783
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortality Surveillance of MRFIT Screenees
- ClinicalTrials.gov ID
- NCT00005156
- Acronym / sponsor ID
- 1028
- Conditions
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident, Coronary Disease, Hypertension, Cardiomyopathy, Congestive
- 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 1982
- Study completion
- Jul 1996
- 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 ascertain the sixteen year mortality status of the 361,662 middle-aged men screened in 1973-1975 for the Multiple Risk Factor Intervention Trial (MRFIT).
Detailed description
BACKGROUND:
The Multiple Risk Factor Intervention Trial was a randomized primary prevention trial to test the effect of a multifactor intervention program on mortality from coronary heart disease in 12,866 high-risk men aged 35 to 57. The primary screening for MRFIT began in November 1973 and continued through November 1, 1975. The primary screening was conducted at clinical center sites, central neighborhood locations, and places of employment. Information was collected on smoking history, blood pressure, serum cholesterol, birthdate, race, and social security number as well as previous hospitalization for a heart attack and use of medication for diabetes. Systolic and diastolic blood pressures were measured and blood drawn for serum cholesterol determinations. The results of the screening examination were transmitted to the Coordinating Center.
DESIGN NARRATIVE:
Using data supplied by the Social Security Administration, the vital status of the MRFIT screenees was determined. A screenee was identified as deceased if the social security number and first two letters of the last name, as recorded on the MRFIT screening form, matched a record on the Social Security Administration master death file. The state health department was contacted to obtain the death certificate which was then coded for the underlying cause of death according to the International Classification of Diseases, 9th Revision. Because the Social Security Adminstration master death file was not completely accurate, the National Death Index was also used. Studies were conducted on the relationships of isolated systolic hypertension to stroke and coronary heart disease mortality, and on seasonal and regional variations in cardiovascular mortality. Using data from the Census Bureau (education and income levels by zip code), the socio-economic status of participants was indirectly estimated and the coronary heart disease and cancer death rate differences between white and Black men were evaluated by social class. Studies were also conducted on the associations of cause- specific cancer mortality and serum cholesterol concentration, and on the association of serum cholesterol, diastolic blood pressure, and cigarettes smoked per day with mortality from coronary heart disease and cerebrovascular disease for Black and white men.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- 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
Not reported in the source record.
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 1 Mar 2016.
- Background: PubMed 6625030Wentworth DN, Neaton JD, Rasmussen WL. An evaluation of the Social Security Administration master beneficiary record file and the National Death Index in the ascertainment of vital status. Am J Public Health. 1983 Nov;73(11):1270-4. doi: 10.2105/ajph.73.11.1270.
- Background: PubMed 6475745Neaton JD, Kuller LH, Wentworth D, Borhani NO. Total and cardiovascular mortality in relation to cigarette smoking, serum cholesterol concentration, and diastolic blood pressure among black and white males followed up for five years. Am Heart J. 1984 Sep;108(3 Pt 2):759-69. doi: 10.1016/0002-8703(84)90669-0.
- Background: PubMed 3946459Stamler J, Wentworth D, Neaton JD. Prevalence and prognostic significance of hypercholesterolemia in men with hypertension. Prospective data on the primary screenees of the Multiple Risk Factor Intervention Trial. Am J Med. 1986 Feb 14;80(2A):33-9. doi: 10.1016/0002-9343(86)90158-0.
- Background: PubMed 3806876Sherwin RW, Wentworth DN, Cutler JA, Hulley SB, Kuller LH, Stamler J. Serum cholesterol levels and cancer mortality in 361,662 men screened for the Multiple Risk Factor Intervention Trial. JAMA. 1987 Feb 20;257(7):943-8.
- Background: PubMed 3773199Stamler J, Wentworth D, Neaton JD. Is relationship between serum cholesterol and risk of premature death from coronary heart disease continuous and graded? Findings in 356,222 primary screenees of the Multiple Risk Factor Intervention Trial (MRFIT). JAMA. 1986 Nov 28;256(20):2823-8.
- Background: PubMed 2877128Martin MJ, Hulley SB, Browner WS, Kuller LH, Wentworth D. Serum cholesterol, blood pressure, and mortality: implications from a cohort of 361,662 men. Lancet. 1986 Oct 25;2(8513):933-6. doi: 10.1016/s0140-6736(86)90597-0.
- Background: PubMed 3532744Kannel WB, Neaton JD, Wentworth D, Thomas HE, Stamler J, Hulley SB, Kjelsberg MO. Overall and coronary heart disease mortality rates in relation to major risk factors in 325,348 men screened for the MRFIT. Multiple Risk Factor Intervention Trial. Am Heart J. 1986 Oct;112(4):825-36. doi: 10.1016/0002-8703(86)90481-3.
- Background: PubMed 3277736Rutan GH, Kuller LH, Neaton JD, Wentworth DN, McDonald RH, Smith WM. Mortality associated with diastolic hypertension and isolated systolic hypertension among men screened for the Multiple Risk Factor Intervention Trial. Circulation. 1988 Mar;77(3):504-14. doi: 10.1161/01.cir.77.3.504.
- Background: PubMed 2619783Iso H, Jacobs DR Jr, Wentworth D, Neaton JD, Cohen JD. Serum cholesterol levels and six-year mortality from stroke in 350,977 men screened for the multiple risk factor intervention trial. N Engl J Med. 1989 Apr 6;320(14):904-10. doi: 10.1056/NEJM198904063201405.
- Background: PubMed 1627030Neaton JD, Blackburn H, Jacobs D, Kuller L, Lee DJ, Sherwin R, Shih J, Stamler J, Wentworth D. Serum cholesterol level and mortality findings for men screened in the Multiple Risk Factor Intervention Trial. Multiple Risk Factor Intervention Trial Research Group. Arch Intern Med. 1992 Jul;152(7):1490-500.
- Background: PubMed 1728930Neaton JD, Wentworth D. Serum cholesterol, blood pressure, cigarette smoking, and death from coronary heart disease. Overall findings and differences by age for 316,099 white men. Multiple Risk Factor Intervention Trial Research Group. Arch Intern Med. 1992 Jan;152(1):56-64.
- Background: PubMed 2345830Neaton JD, Duchene AG, Svendsen KH, Wentworth D. An examination of the efficiency of some quality assurance methods commonly employed in clinical trials. Stat Med. 1990 Jan-Feb;9(1-2):115-23; discussion 124. doi: 10.1002/sim.4780090118.
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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.
James Neaton
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 1 Mar 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005156, which also lists 20 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 1 Mar 2016.