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

Trial Summary

What is the purpose of this trial?

This project is part of the ACHIEVE GREATER (Addressing Cardiometabolic Health Inequities by Early PreVEntion in the GREAT LakEs Region) Center (IRB 100221MP2A), the purpose of which is to reduce cardiometabolic health disparities and downstream Black-White lifespan inequality in two cities: Detroit, Michigan, and Cleveland, Ohio. The ACHIEVE GREATER Center will involve three separate but related projects that aim to mitigate health disparities in risk factor control for three chronic conditions, hypertension (HTN, Project 1), heart failure (HF, Project 2) and coronary heart disease (CHD, Project 3), which drive downstream lifespan inequality. All three projects will involve the use of Community Health Workers (CHWs) to deliver an evidence-based practice intervention program called PAL2. All three projects will also utilize the PAL2 Implementation Intervention (PAL2-II), which is a set of structured training and evaluation strategies designed to optimize CHW competence and adherence (i.e., fidelity) to the PAL2 intervention program. The present study is Project 3 of the ACHIEVE GREATER Center.

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 data supports the effectiveness of the treatment CINEMA, PAL2, PAL2, PAL2 Implementation Intervention (PAL2-II) for coronary heart disease?

The research suggests that programs incorporating therapeutic engagement and continuous care, like the CINEMA and PAL2-II treatments, can improve patient outcomes in coronary heart disease by enhancing adherence to treatment and self-management behaviors. ^{1 2 3 4 5}

Is the Intervention Program for Coronary Heart Disease safe for humans?

The research articles provided do not contain specific safety data for the Intervention Program for Coronary Heart Disease or its related names like CINEMA, PAL2, or PAL2-II. Therefore, no relevant safety information is available from these sources. ^{6 7 8 9 10}

What makes the PAL2 treatment unique for coronary heart disease?

The PAL2 treatment is unique because it focuses on implementing a comprehensive intervention program that includes ongoing reinforcement to improve risk factor modification, which is not typically emphasized in standard treatments for coronary heart disease. ^{2 11 12 13 14}

Research Team

Sanjay Rajagopalan, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

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

You live in the Cleveland Metro Area.

I am between 40 and 75 years old.

Exclusion Criteria

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

I need extra oxygen to breathe properly.

Pregnant or nursing mothers

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2023]

2. Poland pubmed.ncbi.nlm.nih.gov

Long-term outcomes of the Coordinated Care Program in Patients after Myocardial Infarction (KOS-MI). [2023]

3. Japan 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. [2019]

4. England 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. [2022]

5. United States 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. [2023]

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

Clinical impact of a structured secondary cardiovascular prevention program following acute coronary syndromes: A prospective multicenter healthcare intervention. [2020]

7. United States 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. [2018]

8. United States 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. [2022]

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

Feasibility of a Smartphone-enabled Cardiac Rehabilitation Program in Male Veterans With Previous Clinical Evidence of Coronary Heart Disease. [2023]

10. United States 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. [2023]

11. England pubmed.ncbi.nlm.nih.gov

The CHOICE (Choice of Health Options In prevention of Cardiovascular Events) replication trial: study protocol. [2018]

12. Croatia pubmed.ncbi.nlm.nih.gov

[Secondary prevention and cardiac rehabilitation]. [2016]

13. Italy pubmed.ncbi.nlm.nih.gov

[Theoretical bases of health education in cardiology: the secondary prevention of ischemic heart disease]. [2007]

14. England pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation in Canada and Arab countries: comparing availability and program characteristics. [2022]