Epidemiology of Insulin Growth Factor (IGF) and Cardiovascular Events

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00086424
First received: July 1, 2004
Last updated: April 22, 2008
Last verified: April 2008

July 1, 2004
April 22, 2008
July 2004
April 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00086424 on ClinicalTrials.gov Archive Site
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Epidemiology of Insulin Growth Factor (IGF) and Cardiovascular Events
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To explore the role of insulin growth factor in cardiovascular disease in older men and women.

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.

Observational
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  • Cardiovascular Diseases
  • Heart Diseases
  • Coronary Disease
  • Myocardial Infarction
  • Cerebrovascular Accident
  • Heart Failure
  • Heart Failure, Congestive
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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April 2008
April 2008   (final data collection date for primary outcome measure)

No eligibility criteria

Both
65 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00086424
1259
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Robert Kaplan Albert Einstein College of Medicine of Yeshiva University
National Heart, Lung, and Blood Institute (NHLBI)
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP