Completed

Epidemiology of Insulin Growth Factor (IGF) and Cardiovascular Events

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Brain Diseases
+13

+ Cardiovascular Diseases
+ Central Nervous System Diseases
From 65 to 90 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2004
See protocol details

Summary

Principal SponsorAlbert Einstein College of Medicine
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitleEpidemiology of Insulin Growth Factor (IGF) and Cardiovascular Events 
NCT00086424
Principal SponsorAlbert Einstein College of Medicine
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
5888 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

How participants are selected
Participants are chosen using a random method, so everyone has a known and fair chance of being selected. This approach helps ensure the results reflect the broader population.
Another way to select participants is through a non-probability sample, where participants are selected without randomization, often based on availability or willingness to take part.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective: These studies use existing medical records or past data.
Cross-sectional: These studies collect data at one single point in time.
Others: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 65 to 90 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Coronary Disease
Heart Diseases
Heart Failure
Infarction
Ischemia
Myocardial Infarction
Necrosis
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Myocardial Ischemia
Stroke
Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers
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