Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00086424 |
| Other study ID # |
1259 |
| Secondary ID |
5R01HL0755161R01 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 2004 |
| Est. completion date |
April 2008 |
Study information
| Verified date |
June 2018 |
| Source |
Albert Einstein College of Medicine, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
To explore the role of insulin growth factor in cardiovascular disease in older men and
women.
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 cycle/differentiation 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 GH/IGF-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 5,888
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 (MI)/fatal 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
MI/fatal CHD, ischemic stroke, and CHF. Multivariate regression models are used to control
for potential confounding factors including age, sex, race/ethnicity, 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 coagulation/fibrinolysis markers.
