- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00011206
Mortality Follow-Up and Analyses of Men in the MRFIT
Studieoversikt
Status
Detaljert beskrivelse
BACKGROUND:
MRFIT was initiated in 1972 as a randomized, multicenter primary prevention trial designed to determine whether a special intervention consisting of smoking cessation, cholesterol reduction and control of high blood pressure, would result in a significant reduction in coronary heart disease (CHD) mortality, compared to usual care. Follow-up and analysis has continued on the 361,662 men screened and the 12,866 men randomized.
DESIGN NARRATIVE:
The National Death Index (NDI) will be used for continued follow-up of the MRFIT cohorts. An additional assay to establish IGF-1 and IGF binding protein will be added to the data set as a potential prognostic factor. The effort will focus on three primary aims related to long-term mortality. Aim 1 will relate nutritional-dietary data to twenty-five year mortality from coronary heart disease (CHD), stroke, cardiovascular disease (CVD), colon cancer, prostate cancer, and all causes for the 12,866 men randomized. Aim 2 will relate age, ethnicity, socioeconomic position, geographic location, major risk factors, low risk status, prior diabetes, and prior myocardial infarction to twenty-five year mortality for the 361,662 men screened. Aim 3 will relate insulin-like growth factor 1 (IGF-1), IGF binding protein, and fasting and one-hour glucose measurements from frozen baseline sera to mortality for the 12,866 men randomized.
Studietype
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tidsperspektiver: Retrospektiv
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: James Neaton, University of Minnesota
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Domanski M, Mitchell G, Pfeffer M, Neaton JD, Norman J, Svendsen K, Grimm R, Cohen J, Stamler J; MRFIT Research Group. Pulse pressure and cardiovascular disease-related mortality: follow-up study of the Multiple Risk Factor Intervention Trial (MRFIT). JAMA. 2002 May 22-29;287(20):2677-83. doi: 10.1001/jama.287.20.2677.
- Eberly LE, Cohen JD, Prineas R, Yang L; Intervention Trial Research group. Impact of incident diabetes and incident nonfatal cardiovascular disease on 18-year mortality: the multiple risk factor intervention trial experience. Diabetes Care. 2003 Mar;26(3):848-54. doi: 10.2337/diacare.26.3.848.
- Eberly LE, Ockene J, Sherwin R, Yang L, Kuller L; Multiple Risk Factor Intervention Trial Research Group. Pulmonary function as a predictor of lung cancer mortality in continuing cigarette smokers and in quitters. Int J Epidemiol. 2003 Aug;32(4):592-9. doi: 10.1093/ije/dyg177.
- Eberly LE, Stamler J, Neaton JD; Multiple Risk Factor Intervention Trial Research Group. Relation of triglyceride levels, fasting and nonfasting, to fatal and nonfatal coronary heart disease. Arch Intern Med. 2003 May 12;163(9):1077-83. doi: 10.1001/archinte.163.9.1077.
- Vaccaro O, Eberly LE, Neaton JD, Yang L, Riccardi G, Stamler J; Multiple Risk Factor Intervention Trial Research Group. Impact of diabetes and previous myocardial infarction on long-term survival: 25-year mortality follow-up of primary screenees of the Multiple Risk Factor Intervention Trial. Arch Intern Med. 2004 Jul 12;164(13):1438-43. doi: 10.1001/archinte.164.13.1438.
- Prineas RJ, Grandits G, Rautaharju PM, Cohen JD, Zhang ZM, Crow RS; MRFIT Research Group. Long-term prognostic significance of isolated minor electrocardiographic T-wave abnormalities in middle-aged men free of clinical cardiovascular disease (The Multiple Risk Factor Intervention Trial [MRFIT]). Am J Cardiol. 2002 Dec 15;90(12):1391-5. doi: 10.1016/s0002-9149(02)02881-3. No abstract available.
- Gump BB, Matthews KA, Eberly LE, Chang YF; MRFIT Research Group. Depressive symptoms and mortality in men: results from the Multiple Risk Factor Intervention Trial. Stroke. 2005 Jan;36(1):98-102. doi: 10.1161/01.STR.0000149626.50127.d0. Epub 2004 Nov 29.
- Thomas AJ, Eberly LE, Neaton JD, Smith GD; Multiple Risk Factor Intervention Trial Research Group. Latino risk-adjusted mortality in the men screened for the Multiple Risk Factor Intervention Trial. Am J Epidemiol. 2005 Sep 15;162(6):569-78. doi: 10.1093/aje/kwi220. Epub 2005 Aug 2.
- Davey Smith G, Bracha Y, Svendsen KH, Neaton JD, Haffner SM, Kuller LH; Multiple Risk Factor Intervention Trial Research Group. Incidence of type 2 diabetes in the randomized multiple risk factor intervention trial. Ann Intern Med. 2005 Mar 1;142(5):313-22. doi: 10.7326/0003-4819-142-5-200503010-00006.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 963
- R01HL068140 (U.S. NIH-stipend/kontrakt)
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