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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

Must not have

Comorbidity that is expected to limit life expectancy to less than 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 years

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).

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a health condition that may shorten my life to under 5 years.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CVD Events

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 / 2Eligibility criteria met