Novel Strategies for Reducing Heart Disease Risk Disparities

Study acronym: HeartSCORE
StatusActive, Not Recruiting
PhaseNot applicable
Started

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Record History

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  1. 2 versions Re-verified since Sep 17, 2025, no change to tracked fieldsv17-v18
  2. Collaborators shortened, about 4 wordsv16
  3. Re-verified, no change to tracked fieldsv15
  4. Primary and study completion dates: Dec 2024 to Dec 2029v14
  5. 5 versions Re-verified since May 3, 2018, no change to tracked fieldsv9-v13
Show 7 earlier versionsHide 7 earlier versions
  1. Primary endpoint revised
    • Secondary endpoints shortened, about 2 words
    v8
  2. Secondary endpoints: details revised at 1 of 1 entryv7
  3. Primary completion date: Dec 2024
    • Study completion date: Feb 2013 to Dec 2024
    v6
  4. Primary endpoints: 2 to 1v5 Show 6 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Feb 2013
    • Interventions: Nutrition, Exercise, Stress Management Counseling (Behavioral) to Nutrition, Exercise, Stress Management Counseling (Behavioral), usual care (Other)
    • Secondary endpoint revised
    • Site details revised
    • Study arms: 0 to 3
  5. 3 versions Re-verified since Mar 6, 2006, no change to tracked fieldsv2-v4
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00143923
Lead Sponsor University of Pittsburgh
Conditions
(from sponsor)		 Cardiovascular Diseases
Related terms Cardiovascular Diseases, Sleep Apnea Syndromes
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov