Risk Reduction Program for Cardiovascular Disease

Recruiting in Palo Alto (17 mi)

Overseen byEugenia Gianos, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Northwell Health

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of our project is to better understand the characteristics of the young patients with coronary artery disease presenting for cardiac catheterization at our institution and to put forth a program to optimize their risk factors with a focus on gender differences. We will assess traditional and non-traditional risk factors, as well as genetics and environment. These characteristics will be compared by gender to determine unique factors related to women that could subsequently be targeted. The program will begin with universal education about the process of atherosclerosis, risk factors contributing to the disease and specific risk factor goals for each patient for the 6 month program. The patients will then be part of a bimonthly 6 month cardiovascular risk reduction program that will offer both a nutritional program with teaching kitchen component, and exercise instruction lead by an exercise physiologist. Psychological support will be provided to address stress that impairs quality of life, depression or anxiety to fully optimize the lifestyle component. These sessions will be done virtually in order to comply with social distancing until in person sessions can resume. The investigational endpoints of this program will include a variety of cardiovascular disease (CVD) risk factors, biomarkers, lifestyle behaviors, quality of life and guideline-based medical regimen. At the end of this phase, we aim to both better understand differences in risk factors and the interventions with the biggest impact in terms of risk factor optimization in men vs. women.

Research Team

Eugenia Gianos, MD

Principal Investigator

Northwell Health

Eligibility Criteria

The Young Heart Study is for younger adults with coronary artery disease who can participate in exercise and are fluent in English. It's not for those over 60 or with physical limitations that prevent exercising.

Inclusion Criteria

I have heart disease caused by hardening of the arteries.

Exclusion Criteria

I am not fluent in English.

I am 60 years old or older.

I have a physical limitation that stops me from participating in exercise.

Treatment Details

Interventions

Risk Reduction Program (Behavioral Intervention)

Trial OverviewThis study tests a risk reduction program focusing on education, nutrition, exercise, and psychological support to optimize lifestyle factors affecting heart health, especially noting gender differences.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Risk Reduction ProgramExperimental Treatment1 Intervention

All participants will receive education about the process of atherosclerosis, risk factors contributing to the disease and specific risk factor goals for each patient for the 6 month program. The patients will then be part of a bimonthly 6 month cardiovascular risk reduction program that will offer both a nutritional program with teaching kitchen component, and exercise instruction lead by an exercise physiologist. Psychological support will be provided to address stress that impairs quality of life, depression or anxiety to fully optimize the lifestyle component.