Risk Reduction Program for Cardiovascular Disease

Overseen By Eugenia Gianos, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Age 60+, Physical limitations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different factors affect young patients with coronary artery disease, a condition where the heart's blood vessels narrow or become blocked, and to improve their heart health. Participants will join a six-month Risk Reduction Program that includes education on heart disease, a nutrition plan with cooking lessons, and exercise guided by a trainer. The program also provides psychological support to address stress, depression, or anxiety that might impact daily life. This trial suits those under 60 with coronary artery disease who can participate in exercise and speak English fluently. As an unphased trial, it offers a unique opportunity to contribute to understanding and improving heart health in young patients.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this program is safe for participants?

Research has shown that programs aimed at reducing heart disease risk have successfully improved health outcomes. For example, the Million Hearts Cardiovascular Disease Risk Reduction Model effectively prevented heart disease and reduced healthcare costs. This program lowered cholesterol, blood pressure, and smoking rates, leading to nearly a 10% drop in heart disease risk in some studies.

These results suggest that the Risk Reduction Program, which includes lessons on healthy eating, exercise, and mental support, is likely safe and manageable for participants. People in similar programs have not reported major side effects, making it a promising choice for those seeking to care for their heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Risk Reduction Program for cardiovascular disease because it takes a comprehensive lifestyle approach, combining education, nutrition, exercise, and psychological support. Unlike standard treatments that often focus primarily on medication to manage symptoms, this program empowers participants to tackle the root causes of cardiovascular risk factors holistically. By offering a teaching kitchen and exercise guidance led by specialists, along with support for mental health, the program aims to optimize heart health and improve overall quality of life.

What evidence suggests that this program is effective for reducing cardiovascular disease risk?

Research has shown that programs targeting health risk reduction can effectively lower the chances of heart disease and stroke. In one study, participants experienced a 3.3% drop in heart disease and stroke cases. Another study found that these programs reduced the risk of a first-time heart problem by 0.3 percentage points. Additionally, lowering cholesterol levels has decreased heart disease and death rates. This trial will implement a Risk Reduction Program that includes education, nutrition, exercise, and psychological support, aiming to greatly improve heart health and reduce risks. ^{3 6 7 8 9}

Who Is on the Research Team?

Eugenia Gianos, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Baseline characteristics including biometrics and questionnaires are obtained

1 week

1 visit (in-person)

Risk Reduction Program

Participants engage in a 6-month cardiovascular risk reduction program with bi-monthly sessions focusing on nutrition, exercise, and psychological support

6 months

12 sessions (virtual/in-person)

Follow-up

Participants are monitored for changes in cardiovascular risk factors and quality of life

1 month

1 visit (in-person)

Long-term Follow-up

Annual follow-up calls to assess cardiovascular events for up to 5 years

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Risk Reduction Program

Trial Overview 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.

How Is the Trial Designed?

Group I: Risk Reduction Program Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Published Research Related to This Trial

A review of sildenafil citrate (Viagra) safety data revealed that while over 28,000 spontaneous reports were filed, many concerning cardiovascular events were unconfirmed and primarily submitted by non-healthcare professionals, suggesting potential over-reporting of risks.

In contrast, more rigorous data from pooled clinical trials and the International Men's Health Study showed that the rates of myocardial infarction and all-cause mortality for sildenafil were similar to those of a placebo, indicating that the initial safety concerns may not reflect the true risk profile of the drug.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating evidence from multiple sources to evaluate post-approval safety: an example of sildenafil citrate and cardiovascular events. Sobel, RE., Reynolds, RF.[2019]

A study involving 31 health professionals revealed significant gaps in knowledge and fear of punishment as major barriers to effectively reporting adverse events in a teaching hospital.

Improving communication and educational practices between leaders and healthcare professionals is essential to enhance the reporting of adverse events, which is crucial for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The practice of reporting adverse events in a teaching hospital. Siman, AG., Cunha, SGS., Brito, MJM.[2019]

Randomized clinical trials (RCTs) provide valuable initial safety data for drugs, but they often involve a small number of subjects and short follow-up periods, which can leave some safety signals undiscovered until after approval.

The integration of post-marketing real-world data (RWD) with RCT data can enhance safety evaluations, particularly for cardiovascular risks associated with antidiabetic therapies, by identifying new safety signals and validating findings in broader patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative Analysis of Randomized Clinical Trial and Observational Study Data to Inform Post-marketing Safety Decision-Making. Lin, LA., Zhang, Y., Straus, W., et al.[2022]

The nurse-led cardiovascular prevention and rehabilitation program (CVPRP) significantly improved patients' adherence to European cardiovascular health recommendations, with notable increases in healthy behaviors such as fruit and vegetable consumption (98% vs. 53%) and physical activity (31% vs. 12.4%).

The program also led to better clinical outcomes, including improved blood pressure control (69% vs. 47.1%) and lower LDL cholesterol levels (86.1% vs. 67.6%), demonstrating its efficacy in managing risk factors for coronary heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-led and Interdisciplinary Secondary Cardiovascular Prevention Programmes: Spanish Cohort of the EUROACTION Project. Buigues, C., Trapero, I., Velasco, JA., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11068033/

Million Hearts Cardiovascular Disease Risk Reduction Model The main study finding was a 3.3% reduction in a composite outcome of incident coronary heart disease (CHD) and stroke among 130 578 medium- or ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.121.007908

Reducing Cardiovascular Risk in the Medicare Million ... The primary study outcome measure was the percentage reduction in ASCVD risk, among patients with a baseline ASCVD risk of at least 30%, ...

3. jamanetwork.com jamanetwork.com/journals/jama-health-forum/fullarticle/2820779

Scaling the CMS Cardiovascular Risk Reduction Model The final evaluation showed that the model reduced the absolute probability of a first-time CVD event within 5 years by 0.3 percentage points ( ...

4. nature.com nature.com/articles/s41467-024-54078-4

Effectiveness of treat-to-target cholesterol-lowering ... Long-term treat-to-target interventions showed significant reductions in CVD (ARR −2.3%, 95%CI −3.4% to −0.8%; NNT 115), all-cause mortality (−3.0%, −4.3% to

5. sciencedirect.com sciencedirect.com/science/article/pii/S0828282X24003441

What Guidelines Say About Risk Reduction: Major Data on ... We review the recent data that shows a causal link of ApoB lipoproteins with ASCVD; we outline the mounting evidence in favour of aggressive lowering of LDL ...

6. cms.gov cms.gov/priorities/innovation/innovation-models/million-hearts-cvdrrm

Million Hearts: Cardiovascular Disease Risk Reduction ... The Million Hearts CVD Risk Reduction Model supported prevention of CVD, improved health outcomes, and health care cost savings.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9187962/

Reducing Cardiovascular Risk in the Medicare Million ... Achieving a combination of trial-based reductions in cholesterol, blood pressure and smoking rates resulted in a nearly 10% lower practice-level ASCVD risk.

8. ahajournals.org ahajournals.org/doi/10.1161/cir.0000000000000678

2019 ACC/AHA Guideline on the Primary Prevention of ... It addresses the primary prevention of CVD in adults (≥18 years of age), focused on outcomes of ASCVD (ie, acute coronary syndromes, MI, stable or unstable ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8943256/

Atherosclerotic cardiovascular disease risk assessment The foundation of preventive cardiology begins with assessing baseline ASCVD risk using global risk scores based on standard office-based ...