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Active, Not Recruiting

NCT Number: NCT00143923

Novel Strategies for Reducing Heart Disease Risk Disparities

This Western Pennsylvania-based study will (1) improve cardiovascular risk stratification to identify high-risk populations, (2) identify differences in cardiovascular risk, (3) evaluate mechanisms for population differences in cardiovascular risk, and (4) implement a multidisciplinary community-based intervention program to decrease cardiovascular risk in high-risk populations.

This is a prospective cohort study of 2,000 residents of the state of Pennsylvania. All participants will undergo assessments of traditional and nontraditional risk factors to identify and determine the mechanisms of population disparities in cardiovascular risk. 800 participants who are at intermediate or high risk of cardiovascular disease will be randomly assigned to either (1) usual care/"advice only"; or (2) a multidisciplinary behavioral modification program to determine the most effective approach to reduce or eliminate differences in cardiovascular risk among high risk populations. All participants will undergo long-term follow-up for cardiovascular events.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiovascular Diseases Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

Well-established disparities exist in the prevalence and outcome of cardiovascular disease related to race and socioeconomic status (SES). Our previous work confirms these disparities and suggests that they may be related to population differences in the prevalence of nontraditional cardiovascular risk factors. We propose that these disparities can be significantly reduced or eliminated by (1) a community-based intervention program that incorporates a multidisciplinary education program led by a behavioral interventionalist, a nutritionist and an exercise physiologist, and (2) a novel approach to cardiovascular risk stratification that considers population differences in traditional and nontraditional risk factors and subclinical atherosclerosis.

To successfully implement this program, particularly in traditionally underserved communities, we have formalized a partnership between the University of Pittsburgh School of Medicine and Graduate School of Public Health, the Pittsburgh Mind-Body Center, and the Pittsburgh Theological Seminary, Urban League of Pittsburgh, and Jewish Healthcare Foundation. This partnership is positioned to study the following specific aims:

  • To determine whether a community-based intervention program that incorporates a multidisciplinary education program led by a behavioral interventionalist, a nutritionist, and an exercise physiologist can reduce racial and socioeconomic disparities in cardiovascular risk in intermediate and high risk populations.
  • To ascertain whether a comprehensive assessment of nontraditional risk factors and subclinical atherosclerosis can provide incremental value above and beyond traditional risk assessment in identifying individuals at high cardiovascular risk.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women age 45-75 years

Exclusion criteria

  • Comorbidity that is expected to limit life expectancy to <5 years
  • Inability to undergo baseline or annual follow-up visits
  • Pregnancy (exclude women from Xray studies)

Treatment and study plan

Nutrition, Exercise, Stress Management Counseling

Behavioral

Individualized advice

Usual Care

Other

usual care

Primary outcomes

  1. CVD Events

    Time frame: 20 years

    Major adverse cardiovascular events

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Heart Strategies Concentrating On Risk Evaluation (Heart SCORE) Study

Acronym: HeartSCORE

Important dates

Study start
2003
Primary completion
2029
Study completion
2029
First posted
Sep 2, 2005
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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