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Epidemiology of Insulin Growth Factor (IGF) and Cardiovascular Events

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00086424
First Posted: July 5, 2004
Last Update Posted: April 23, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type: Observational

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: July 2004
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
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 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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00086424


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Robert Kaplan Albert Einstein College of Medicine, Inc.
  More Information

ClinicalTrials.gov Identifier: NCT00086424     History of Changes
Other Study ID Numbers: 1259
First Submitted: July 1, 2004
First Posted: July 5, 2004
Last Update Posted: April 23, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Heart Failure
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
Stroke
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases