Clincosm LogoSign in Get a demo

Epidemiology of Insulin Growth Factor (IGF) and Cardiovascular Events

Sponsor
Albert Einstein College of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT00086424
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH), National Institute on Aging (NIA) (NIH)
5,888
Enrollment
45
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    5888 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Epidemiology of Insulin Growth Factor (IGF) and Cardiovascular Events
    Study Start Date :
    Jul 1, 2004
    Actual Primary Completion Date :
    Apr 1, 2008
    Actual Study Completion Date :
    Apr 1, 2008

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      65 Years to 90 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No

      Medicare-eligible adults as well as other age-eligible individuals residing in the household

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Albert Einstein College of Medicine
      • National Heart, Lung, and Blood Institute (NHLBI)
      • National Institute on Aging (NIA)

      Investigators

      • Principal Investigator: Robert C Kaplan, Ph.D., Albert Einstein College of Medicine

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Robert Kaplan, Prof. Epidemiology & Population Health, Albert Einstein College of Medicine
      ClinicalTrials.gov Identifier:
      NCT00086424
      Other Study ID Numbers:
      • 1259
      • 5R01HL075516
      • 1R01AG031890
      • 2003-020
      First Posted:
      Jul 5, 2004
      Last Update Posted:
      Jun 14, 2018
      Last Verified:
      Jun 1, 2018
      Studies a U.S. FDA-regulated Drug Product:
      No
      Studies a U.S. FDA-regulated Device Product:
      No
      Additional relevant MeSH terms:
      Stroke
      Heart Failure
      Cardiovascular Diseases
      Myocardial Infarction
      Heart Diseases
      Coronary Disease
      Infarction

      Study Results

      No Results Posted as of Jun 14, 2018