Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086424
Status:
COMPLETED
Last Update Posted:
2018-06-14
First Post:
2004-07-01
Brief Title:
Epidemiology of Insulin Growth Factor IGF and Cardiovascular Events
Sponsor:
Albert Einstein College of Medicine
Organization:
Albert Einstein College of Medicine
Study Overview
Official Title:
Epidemiology of Insulin Growth Factor IGF and Cardiovascular Events
Status:
COMPLETED
Status Verified Date:
2018-06
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 explore the role of insulin growth factor in cardiovascular disease in older men and women
Detailed Description:
BACKGROUND
Insulin-like growth factor-I IGF-I is the main mediator of effects of growth hormone GH and an important regulator of cell cycledifferentiation and inhibitor of apoptosis Consistent with laboratory studies showing potentially beneficial effects of IGF-I on the cardiovascular and cerebrovascular systems GH-deficient individuals have high cardiovascular disease CVD mortality and evidence of premature atherosclerotic disease that is reversible with GH replacement In addition several epidemiological and clinical studies have shown an association between low serum IGF-I levels and myocardial infarction MI and congestive heart failure CHF among persons without frank abnormalities of the GHIGF-I axis
DESIGN NARRATIVE
The study is the first prospective investigation to assess whether serum levels of IGF-I and two of its important binding proteins IGFBP-3 and IGFBP-1 are associated with incidence of confirmed incident cardiovascular disease CVD events in older male and female adults Specimens and data for this study will be obtained from the Cardiovascular Health Study CHS a large multi-center NHLBI-funded prospective cohort study of 5888 community-dwelling men and women 65 years or older The study uses an efficient case-cohort study design to select specimens for testing involving evaluation of 750 incident myocardial infarction MIfatal coronary heart disease CHD cases 500 incident stroke cases 750 incident congestive heart failure CHF cases and a comparison sub-cohort of 750 individuals selected at random from the study population The study examines the association between baseline serum IGF-I IGFBP-1 and IGFBP-3 level and the future occurrence of first incident MIfatal CHD ischemic stroke and CHF Multivariate regression models are used to control for potential confounding factors including age sex raceethnicity anthropometry and body composition fasting and 2-hour post-load glucose and insulin levels dietary intake physical activity hormone replacement therapy and other medications and other CVD risk markers such as lipids inflammatory factors and coagulationfibrinolysis markers
Insulin-like growth factor-I IGF-I is the main mediator of effects of growth hormone GH and an important regulator of cell cycledifferentiation and inhibitor of apoptosis Consistent with laboratory studies showing potentially beneficial effects of IGF-I on the cardiovascular and cerebrovascular systems GH-deficient individuals have high cardiovascular disease CVD mortality and evidence of premature atherosclerotic disease that is reversible with GH replacement In addition several epidemiological and clinical studies have shown an association between low serum IGF-I levels and myocardial infarction MI and congestive heart failure CHF among persons without frank abnormalities of the GHIGF-I axis
DESIGN NARRATIVE
The study is the first prospective investigation to assess whether serum levels of IGF-I and two of its important binding proteins IGFBP-3 and IGFBP-1 are associated with incidence of confirmed incident cardiovascular disease CVD events in older male and female adults Specimens and data for this study will be obtained from the Cardiovascular Health Study CHS a large multi-center NHLBI-funded prospective cohort study of 5888 community-dwelling men and women 65 years or older The study uses an efficient case-cohort study design to select specimens for testing involving evaluation of 750 incident myocardial infarction MIfatal coronary heart disease CHD cases 500 incident stroke cases 750 incident congestive heart failure CHF cases and a comparison sub-cohort of 750 individuals selected at random from the study population The study examines the association between baseline serum IGF-I IGFBP-1 and IGFBP-3 level and the future occurrence of first incident MIfatal CHD ischemic stroke and CHF Multivariate regression models are used to control for potential confounding factors including age sex raceethnicity anthropometry and body composition fasting and 2-hour post-load glucose and insulin levels dietary intake physical activity hormone replacement therapy and other medications and other CVD risk markers such as lipids inflammatory factors and coagulationfibrinolysis markers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 5R01HL075516 | NIH | None | None |
| 1R01AG031890 | NIH | None | None |
| 2003-020 | OTHER | Albert Einstein College of Medicine-IRB | httpsreporternihgovquickSearch1R01AG031890 |