Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011206
Status:
COMPLETED
Last Update Posted:
2014-03-17
First Post:
2001-02-13
Brief Title:
Mortality Follow-Up and Analyses of Men in the MRFIT
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To extend mortality followup through 25 years for two cohorts of men in the Multiple Risk Factor intervention Trial MRFIT the 361662 men screened and the 12866 men randomized and to pursue the general aim of elucidating unresolved research issues on the epidemiology natural history etiology prevention and control of major chronic diseases particularly cardiovascular and neoplastic diseases and diabetes
Detailed Description:
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 361662 men screened and the 12866 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 12866 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 361662 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 12866 men randomized
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 361662 men screened and the 12866 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 12866 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 361662 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 12866 men randomized
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL068140 | NIH | None | httpsreporternihgovquickSearchR01HL068140 |