Mortality Surveillance of MRFIT Screenees

Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005156
• Other study ID #: 1028
• Secondary ID: R01HL028715
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: February 29, 2016
• Start date: April 1982
• Est. completion date: July 1996

Study information

• Verified date: February 2016
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 1996
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Congestive
• Cardiomyopathy, Dilated
• Cardiovascular Diseases
• Cerebrovascular Accident
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Hypertension
• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (20)

Coughlin 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. — View Citation

Iso 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. — View Citation

Kannel 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. — View Citation

Klag 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. — View Citation

Martin 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. — View Citation

Neaton 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. — View Citation

Neaton 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. — View Citation

Neaton 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. — View Citation

Neaton 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. — View Citation

Neaton 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. — View Citation

Rutan 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. Review. — View Citation

Sherwin 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. — View Citation

Smith GD, Neaton JD, Wentworth D, Stamler R, Stamler J. Socioeconomic differentials in mortality risk among men screened for the Multiple Risk Factor Intervention Trial: I. White men. Am J Public Health. 1996 Apr;86(4):486-96. — View Citation

Smith GD, Wentworth D, Neaton JD, Stamler R, Stamler J. Socioeconomic differentials in mortality risk among men screened for the Multiple Risk Factor Intervention Trial: II. Black men. Am J Public Health. 1996 Apr;86(4):497-504. — View Citation

Stamler J, Daviglus ML, Garside DB, Dyer AR, Greenland P, Neaton JD. Relationship of baseline serum cholesterol levels in 3 large cohorts of younger men to long-term coronary, cardiovascular, and all-cause mortality and to longevity. JAMA. 2000 Jul 19;284(3):311-8. — View Citation

Stamler J, Stamler R, Neaton JD, Wentworth D, Daviglus ML, Garside D, Dyer AR, Liu K, Greenland P. Low risk-factor profile and long-term cardiovascular and noncardiovascular mortality and life expectancy: findings for 5 large cohorts of young adult and middle-aged men and women. JAMA. 1999 Dec 1;282(21):2012-8. — View Citation

Stamler J, Vaccaro O, Neaton JD, Wentworth D. Diabetes, other risk factors, and 12-yr cardiovascular mortality for men screened in the Multiple Risk Factor Intervention Trial. Diabetes Care. 1993 Feb;16(2):434-44. — View Citation

Stamler 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. — View Citation

Stamler 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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references