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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the Risk Reduction Program treatment for cardiovascular disease?

Research shows that comprehensive cardiovascular risk reduction programs, which include lifestyle changes and medical treatments, can significantly improve health outcomes for people with heart disease. These programs have been shown to reduce weight, blood sugar, and blood pressure, and improve overall survival and quality of life. ^{1 2 3 4 5}

Is the Risk Reduction Program for Cardiovascular Disease generally safe for humans?

The safety of cardiovascular disease treatments is often evaluated through various studies, including those that analyze adverse drug reactions reported in databases like the FDA's. These studies help ensure that any potential risks are identified and managed, contributing to the overall safety of such programs. ^{6 7 8 9 10}

How is the Risk Reduction Program treatment different from other treatments for cardiovascular disease?

The Risk Reduction Program is unique because it combines reducing cardiovascular risk factors with ongoing professional support, which helps maintain motivation and reinforce healthy habits, leading to improvements in weight, blood sugar, and blood pressure. ^{2 4 5 11 12}

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.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The challenge of risk reduction therapy for cardiovascular disease. [2007]

2. Chile pubmed.ncbi.nlm.nih.gov

[Cardiovascular risk factors among males in 1989 and 2011-12 in a southern Chilean city]. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Comprehensive cardiovascular disease risk reduction in a cardiac rehabilitation setting. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Professional support: an essential component in a cardiovascular risk reduction program. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy of the Berkshire Health System Cardiovascular Health Risk Reduction Program. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

A Pharmacovigilance Study of Adverse Drug Reactions Reported for Cardiovascular Disease Medications Approved Between 2012 and 2017 in the United States Food and Drug Administration Adverse Event Reporting System (FAERS) Database. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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

8. Brazil pubmed.ncbi.nlm.nih.gov

Dante Pazzanese risk score for non-st-segment elevation acute coronary syndrome. [2019]

9. Brazil pubmed.ncbi.nlm.nih.gov

The practice of reporting adverse events in a teaching hospital. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Integrative Analysis of Randomized Clinical Trial and Observational Study Data to Inform Post-marketing Safety Decision-Making. [2022]

11. Chile pubmed.ncbi.nlm.nih.gov

[Achievement of cardiovascular prevention goals, pharmacologic prescription and major cardiovascular events among patients with coronary disease]. [2013]

12. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Nurse-led and Interdisciplinary Secondary Cardiovascular Prevention Programmes: Spanish Cohort of the EUROACTION Project. [2022]