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Lifestyle Interventions for Heart Disease Risk Reduction (HeartSCORE Trial)

N/A

Waitlist Available

Led By Steven E Reis, MD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men and women age 45-75 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 years

Awards & highlights

HeartSCORE Trial Summary

This trial will improve cardiovascular risk stratification, identify disparities in risk based on race and location, and evaluate mechanisms for population differences in risk. A multidisciplinary community-based intervention program will be implemented to decrease cardiovascular risk in high-risk populations.

Who is the study for?

This trial is for Pennsylvania residents aged 45-75 who may be at risk of heart disease. It's not suitable for those with a life expectancy under 5 years, unable to attend regular visits, or pregnant women (excluded from X-ray studies).Check my eligibility

What is being tested?

The study tests if better risk identification and community programs like nutrition advice, exercise routines, and stress management can reduce heart disease risks in high-risk groups. Participants will either receive usual care or join the intervention program.See study design

What are the potential side effects?

Since this trial involves lifestyle changes rather than medication, side effects are minimal but could include muscle soreness from new exercise routines or adjustment issues to dietary changes.

HeartSCORE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 45 and 75 years old.

HeartSCORE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CVD Events

HeartSCORE Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: 1Active Control1 Intervention

Intervention: 6 months of individualized advice regarding Nutrition, Exercise, Stress Management Counseling for participants who are at intermediate or high Framingham risk for CVD and are randomized to Arm 1

Group II: 3Active Control1 Intervention

No intervention for all participants who are at low Framingham risk for CVD or have preexisting CVD prior to study entry/ No active Nutrition, Exercise, Stress Management Counseling

Group III: 2Placebo Group1 Intervention

Intervenition: 6 months of Usual care for participants who are at intermediate or high Framingham risk for CVD and are randomized to Arm 2. No active Nutrition, Exercise, Stress Management Counseling

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pennsylvania Department of HealthOTHER_GOV

41 Previous Clinical Trials

996,395 Total Patients Enrolled

University of PittsburghLead Sponsor

1,719 Previous Clinical Trials

16,340,341 Total Patients Enrolled

Steven E Reis, MDPrincipal InvestigatorUniversity of Pittsburgh

Media Library

usual care Clinical Trial Eligibility Overview. Trial Name: NCT00143923 — N/A

Cardiovascular Disease Research Study Groups: 1, 2, 3

Cardiovascular Disease Clinical Trial 2023: usual care Highlights & Side Effects. Trial Name: NCT00143923 — N/A

usual care 2023 Treatment Timeline for Medical Study. Trial Name: NCT00143923 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for inclusion in this research project restricted to under 45 years old?

"Qualified candidates for this trial should have attained the age of 45, but not surpassed 75."

Answered by AI

Is there still availability for volunteers to partake in this research?

"Clinicaltrials.gov confirms that this trial is not presently recruiting, as the posting was last modified on April 6th 2022. However, there are 415 other studies which still need participants at present."

Answered by AI

Might I partake in this experiment based on my qualifications?

"This clinical trial requires that prospective participants have some form of cardiovascular affliction and are aged between 45 and 75. Approximately 2000 individuals will be accepted into the medical study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Novel Strategies for Reducing Heart Disease Risk Disparities

Steven E. Reis, MD 2003. "Novel Strategies for Reducing Heart Disease Risk Disparities". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00143923.

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