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Epidemiology of Insulin Growth Factor (IGF) and Cardiovascular Events - Article


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Heart arrhythmias



Clinical Trial: Epidemiology of Insulin Growth Factor (IGF) and Cardiovascular Events

This study is no longer recruiting patients.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)

Purpose

To explore the role of insulin growth factor in cardiovascular disease in older men and women.

Condition
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Myocardial Infarction
Cerebrovascular Accident
Heart Failure
Heart Failure, Congestive

MedlinePlus related topics:  Cardiomyopathy;   Coronary Disease;   Heart Attack;   Heart Diseases;   Heart Diseases--Prevention;   Heart Failure;   Stroke;   Vascular Diseases

Study Type: Observational
Study Design: Natural History, Defined Population

Further Study Details: 

Study start: July 2004;  Study completion: April 2006

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.

Eligibility

Ages Eligible for Study:  65 Years   -   90 Years,  Genders Eligible for Study:  Both

Criteria

No eligibility criteria

Location Information

Study chairs or principal investigators

Robert Kaplan,  Albert Einstein College of Medicine   

More Information

Study ID Numbers:  1259
Record last reviewed:  December 2004
Last Updated:  January 10, 2005
Record first received:  July 1, 2004
ClinicalTrials.gov Identifier:  NCT00086424
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 18, 2008



Page Updated: October 1, 2005
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