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Risk Reduction Program for Cardiovascular Disease

N/A
Waitlist Available
Led By Eugenia Gianos, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient with atherosclerotic cardiovascular disease
Be between 18 and 65 years old
Must not have
Participants not fluent in English
Age 60 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is designed to better understand how to optimize risk factors for young patients with coronary artery disease, with a focus on gender differences. Patients will be part of a 6 month program that includes education, nutritional and exercise instruction, and psychological support. The goal is to improve quality of life and reduce risk factors.

Who is the study for?
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.
What is being tested?
This 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.
What are the potential side effects?
Since this trial involves lifestyle changes rather than medication, side effects may include muscle soreness from exercise and potential stress from dietary changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have heart disease caused by hardening of the arteries.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not fluent in English.
Select...
I am 60 years old or older.
Select...
I have a physical limitation that stops me from participating in exercise.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Change in CV Risk Factor - Blood pressure
Change in CV Risk Factor - Glucometabolic state (A1C)
Change in CV Risk Factor - Overweight/Obesity
+7 more
Secondary study objectives
Number of Cardiovascular events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
474 Previous Clinical Trials
469,100 Total Patients Enrolled
3 Trials studying Coronary Artery Disease
1,543 Patients Enrolled for Coronary Artery Disease
Eugenia Gianos, MD5.08 ReviewsPrincipal Investigator - Northwell Health
Northwell Health
5Patient Review
She is both detail-oriented and compassionate. She is willing to take the time to listen to you.

Media Library

Risk Reduction Program Clinical Trial Eligibility Overview. Trial Name: NCT04462159 — N/A
Coronary Artery Disease Research Study Groups: Risk Reduction Program
Coronary Artery Disease Clinical Trial 2023: Risk Reduction Program Highlights & Side Effects. Trial Name: NCT04462159 — N/A
Risk Reduction Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT04462159 — N/A
~11 spots leftby Nov 2025