Intervention Program for Coronary Heart Disease

Overseen By Heidi Osborne

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Disqualifiers: Cardiovascular disease, Cancer, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve heart health in Black or African American individuals through a program called PAL2. The goal is to address health issues like coronary heart disease, which often lead to shorter lifespans. Participants will collaborate with Community Health Workers to manage their conditions. The trial is best suited for those living in the Cleveland Metro Area with risk factors such as high blood pressure, a history of smoking, or high cholesterol. As an unphased trial, it offers a unique opportunity to contribute to important research that could lead to better heart health solutions for the community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intervention program is safe?

Research has shown that the PAL2 program, used in community health settings, is generally well-tolerated by patients. One study on its use for heart failure suggested it usually doesn't cause serious side effects. The program helps patients manage their heart health better, often through support and education from trained community health workers.

For the CINEMA approach, aimed at people with high cardiovascular risk, specific safety information isn't available in the sources. However, this type of care often involves team-based, patient-focused strategies, which are generally considered safe. Participants should discuss possible risks with their healthcare providers before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PAL2 for coronary heart disease because it offers a novel approach to managing cardiovascular risks. Unlike traditional treatments like statins and beta-blockers, which primarily focus on lowering cholesterol and blood pressure, PAL2 is part of a broader intervention program that aims to integrate and innovate vascular-metabolic disease management. This approach could potentially address coronary heart disease more comprehensively by considering various cardiovascular risk factors, allowing for personalized treatment strategies.

What evidence suggests that this trial's treatments could be effective for coronary heart disease?

Research has shown that the CINEMA program, a treatment option in this trial, can lower the predicted 10-year risk of heart disease by about 2.4%, benefiting heart health. This program also aids individuals with coronary artery disease by reducing post-hospitalization complications. In contrast, the PAL2 intervention, another treatment option in this trial, manages heart disease risk factors. It aims to be cost-effective and enhance heart health through structured support and education. Both treatments in this trial show promise in managing heart disease by addressing key risk factors and improving patient outcomes. ^{1 6 7 8 9}

Who Is on the Research Team?

Sanjay Rajagopalan, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

This trial is for Black or African American individuals aged 40-75 living in the Cleveland Metro Area, with certain risk factors like high body mass index (BMI), history of smoking, elevated blood pressure, high HbA1c or LDL levels. They must be able to undergo a coronary artery calcium score test and consent to treatment by a UH provider within their insurance coverage.

Inclusion Criteria

Self-identified as Black or African American

I am between 40 and 75 years old.

You live in the Cleveland Metro Area.

Exclusion Criteria

Your blood pressure is very high (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg).

Pregnant or nursing mothers

I need extra oxygen to breathe properly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Community Health Workers deliver the PAL2 intervention program to participants

12 months

Regular visits as per intervention protocol

Follow-up

Participants are monitored for health visits and lifestyle changes, including smoking cessation and diet

12 months after cessation of intervention

Periodic health assessments

What Are the Treatments Tested in This Trial?

Interventions

• CINEMA
• PAL2

Trial Overview Project 3: ACHIEVE-CHD is testing an intervention program called PAL2 delivered by Community Health Workers. It's part of a larger effort to reduce health disparities in heart disease management among populations at risk in Detroit and Cleveland.

How Is the Trial Designed?

Group I: Low CVD risk Experimental Treatment 1 Intervention

PAL2

Group II: High CVD risk Experimental Treatment 1 Intervention

Center for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA)

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Published Research Related to This Trial

Coronary heart disease requires a multidisciplinary approach for effective treatment, emphasizing the importance of a structured cardiac rehabilitation program that includes secondary prevention to help patients regain their ability to live normal lives.

Patients who undergo tailored cardiac rehabilitation programs, guided by healthcare professionals, are better equipped to manage their health and maintain long-term benefits, with ongoing support from their general practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Secondary prevention and cardiac rehabilitation]. Jembrek-Gostović, M., Jonke, V., Gostović, M., et al.[2016]

An 18-month complex intervention aimed at improving care for patients with coronary heart disease significantly reduced hospital admissions compared to usual care, with 25.8% of the intervention group admitted versus 34.0% in the control group.

However, the intervention did not lead to significant improvements in blood pressure or cholesterol levels, suggesting that patients may have already been receiving optimal management for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of tailored practice and patient care plans on secondary prevention of heart disease in general practice: cluster randomised controlled trial. Murphy, AW., Cupples, ME., Smith, SM., et al.[2022]

The transitional care program significantly reduced 30 and 90-day readmission rates for patients with coronary heart disease compared to usual care, based on a randomized controlled trial with 236 participants.

Patients in the transitional care program also reported better quality-of-care transitions, higher medication adherence, and improved chronic disease self-efficacy at both 30 and 90 days post-discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a hospital-community partnership transitional program in patients with coronary heart disease in Chengdu, China: A randomized controlled trial. Cao, XY., Tian, L., Chen, L., et al.[2019]

A mutual goal-based continuous care program significantly improved self-management behaviors, quality of life, and patient satisfaction in 87 patients with coronary heart disease after percutaneous coronary intervention, compared to standard care.

The program also resulted in a lower unscheduled readmission rate (4.76% vs. 22.22%) for the study group, indicating its potential effectiveness in enhancing patient outcomes post-PCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a mutual goal-based continuous care program on self-management behaviour and health outcomes in patients after percutaneous coronary intervention: A randomized controlled trial. Zhu, X., Yang, Y., Cao, M.[2023]

A structured secondary cardiovascular prevention program (SSCP) improved attendance to cardiac rehabilitation and helped patients achieve better control of cardiovascular risk factors, although it did not significantly reduce major adverse cardiovascular events (MACE) overall.

For patients aged 65 and younger, the SSCP was associated with a significant reduction in cardiac death, myocardial infarction (MI), and stroke, highlighting its potential effectiveness in younger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of a structured secondary cardiovascular prevention program following acute coronary syndromes: A prospective multicenter healthcare intervention. Carballo, D., Rodondi, N., Auer, R., et al.[2020]

In a study of 15,388 patients, 30% had extensive coronary artery disease (CAD), which was linked to higher rates of cardiovascular events and a lower likelihood of undergoing percutaneous coronary intervention.

Ticagrelor was found to significantly reduce the risk of cardiovascular death, myocardial infarction, and stroke in patients with extensive CAD, with similar bleeding rates compared to clopidogrel, indicating its efficacy and safety across different CAD severities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extent of coronary artery disease and outcomes after ticagrelor administration in patients with an acute coronary syndrome: Insights from the PLATelet inhibition and patient Outcomes (PLATO) trial. Kotsia, A., Brilakis, ES., Held, C., et al.[2018]

The INTERASPIRE survey aims to gather comprehensive data on coronary heart disease (CHD) patients across various countries, focusing on the prevalence of cardiometabolic and renal risk factors, as well as biomarkers.

This study will assess how well current risk factor management aligns with international guidelines and explore variations in preventive cardiology practices globally, ultimately promoting better preventive care for CHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

INTERASPIRE: an International Survey of Coronary Patients; Their Cardiometabolic, Renal and Biomarker Status; and the Quality of Preventive Care Delivered in All WHO Regions : In Partnership with the World Heart Federation, European Society of Cardiology, Asia Pacific Society of Cardiology, InterAmerican Society of Cardiology, and PanAfrican Society of Cardiology. McEvoy, JW., Jennings, C., Kotseva, K., et al.[2022]

A smartphone-enabled, home-based cardiac rehabilitation program was found to be feasible for veterans with coronary heart disease, with 13 out of 18 participants completing the full 12-week intervention.

Participants showed significant improvements in functional capacity and systolic blood pressure, indicating that this approach can effectively enhance health outcomes while maintaining high levels of patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Smartphone-enabled Cardiac Rehabilitation Program in Male Veterans With Previous Clinical Evidence of Coronary Heart Disease. Harzand, A., Witbrodt, B., Davis-Watts, ML., et al.[2023]

The CRAX2MACE model, designed to predict 2-year major adverse cardiac events (MACE) in patients with suspected coronary artery disease (CAD), showed limited predictive value in an external validation study of 1003 patients, with an area under the curve of only 0.612.

The model's performance was particularly poor for predicting hard events like cardiac death and acute myocardial infarction, indicating that it may not be reliable for clinical decision-making in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External validation of the CRAX2MACE model in an Italian cohort of patients with suspected coronary artery disease undergoing stress myocardial perfusion imaging. Megna, R., Petretta, M., Assante, R., et al.[2023]

In a study of 88 patients who underwent coronary artery bypass graft (CABG), an enhanced cardiac rehabilitation program that included therapeutic engagement and remote support significantly improved medication adherence and sense of coherence over three months compared to a traditional program.

The experimental group showed consistent improvements at each assessment point, while the control group only had significant changes up to one month, highlighting the long-term benefits of the enhanced rehabilitation approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the effect of the Model of Therapeutic Engagement in cardiac rehabilitation on the sense of coherence and adherence to treatment: a randomized clinical trial. Pakrad, F., Jahandideh, S., Oshvandi, K., et al.[2023]

Effective secondary prevention of ischemic heart disease requires timely recognition and treatment of various conditions like myocardial infarction and heart failure, emphasizing the need for a comprehensive approach.

A 15-year education and counseling program highlights the importance of patient involvement and motivation, suggesting that successful prevention strategies must engage patients, families, and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Theoretical bases of health education in cardiology: the secondary prevention of ischemic heart disease]. Passerelli, A., Vanuzzo, D., Maisano, G.[2007]

The study aims to evaluate the effectiveness of the CHOICE program for secondary prevention of coronary heart disease (CHD) in acute coronary syndrome (ACS) survivors, comparing a standard 3-month program to an extended 30-month program with ongoing reinforcement.

Primary outcomes will assess improvements in key health metrics such as lipid levels, blood pressure, and physical activity, with secondary outcomes including readmission rates and quality of life over a three-year period, involving multiple sites and a randomized control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The CHOICE (Choice of Health Options In prevention of Cardiovascular Events) replication trial: study protocol. Neubeck, L., Redfern, J., Briffa, T., et al.[2018]

The KOS-MI program, which includes complete revascularization and access to rehabilitation, significantly reduces the risk of major adverse cardiac and cerebrovascular events (MACCE) by 25% compared to standard care over a 3-year follow-up with 963 patients in the KOS-MI group.

Patients in the KOS-MI program also experienced a 38% reduction in mortality and a 29% decrease in the need for repeated revascularization, highlighting the program's effectiveness in improving long-term outcomes after myocardial infarction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes of the Coordinated Care Program in Patients after Myocardial Infarction (KOS-MI). Kolarczyk-Haczyk, A., Konopko, M., Mazur, M., et al.[2023]

Cardiac rehabilitation (CR) programs are very limited in the Arab world, with only 8 programs identified and 5 participating in the study, compared to 128 programs in Canada, of which 39 participated.

Despite the limited availability, the core components of CR programs in Arab countries are similar to those in Canada, with a notable emphasis on women-only classes, highlighting a cultural adaptation in program delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation in Canada and Arab countries: comparing availability and program characteristics. Turk-Adawi, KI., Terzic, C., Bjarnason-Wehrens, B., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10787236/

Second-year results from CINEMA: A novel, patient-centered ... Absolute 10-year predicted ASCVD risk decreased by ∼2.4 % (p<0.001) with the intervention. In addition, rates of guideline-directed ...

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.120.024482

Year 1 Results From the CINEMA Program Coronary artery disease, 133 (65), 71 (63), 62 (67), 0.57. Heart failure, 86 (42), 44 (39), 42 (45), 0.37. Prior endocrinology visit, 88 (43) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11198697/

Digital Health Programs to Reduce Readmissions in Coronary ... The purpose of this study was to undertake a systematic review and meta-analysis of mHealth-enabled DMPs to determine their effectiveness in reducing ...

4. researchgate.net researchgate.net/publication/376742366_Second-Year_Results_from_CINEMA_A_Novel_Patient-Centered_Team-Based_Intervention_for_Patients_with_Type_2_Diabetes_or_Prediabetes_at_High_Cardiovascular_Risk

A Novel, Patient-Centered, Team-Based Intervention for ... Methods and Results We report 2-year results from a patient-centered, team-based intervention called CINEMA at University Hospitals Cleveland Medical Center.

5. nature.com nature.com/articles/s41746-025-01655-6

Effectiveness of digital healthcare to improve clinical ... Digital healthcare demonstrates superior post-discharge optimization of CAD outcomes, significantly attenuating mortality and morbidity.

6. arxiv.org arxiv.org/html/2506.00679v1

CineMA: A Foundation Model for Cine Cardiac MRI CineMA showed superior segmentation accuracy and more precise and consistent ejection fraction estimates, especially in low-data settings.

7. eurointervention.pcronline.com eurointervention.pcronline.com/article/safety-and-feasibility-of-a-low-frame-rate-protocol-for-percutaneous-coronary-intervention-to-chronic-total-occlusions-preliminary-experience

Safety and feasibility of a low frame rate protocol for ... This study evaluated the safety and feasibility of a low frame rate protocol for CTO-PCI that achieved a 60-72.5% reduction in radiation exposure without ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2772963X23005434

Digital Health Programs to Reduce Readmissions in ... There was no significant reduction for mortality outcomes (RR: 1.72; 95% CI: 0.64-4.64) or major adverse cardiovascular events (RR: 0.68; 95% CI: 0.40-1.15).

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8507088/

Efficacy and safety of coronary stent intervention for ... Coronary stent interventional therapy has better clinical efficacy and short-term and long-term prognosis for CHD patients than drug therapy alone.