Lifestyle Modification for Coronary Artery Disease

(Century Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must be taking: Lipid lowering

Disqualifiers: Unstable angina, Recent MI, Recent stroke, Severe renal dysfunction, others

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

Compensation: Varies

Number of Visits: 6

Duration: 5 years

1085 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The Century Trial is a single center Phase III randomized study sponsored by the Albert Weatherhead III Foundation and conducted by Dr. K. Lance Gould. The study hypothesis is that a combined image-treatment regimen of PET + comprehensive program of lifestyle modification and lipid lowering drugs to target lipid level will result in an improved cardiovascular risk score when compared to current standard optimal medical therapy, potentially resulting in a lower rate of death, non-fatal myocardial infarction (MI) and revascularization procedures during long term follow-up when compared with current standard of care. If our hypothesis is correct, we will not only improve our ability to prevent and treat CAD but we will also illustrate that, even with the expenses of behavioral interventions and imaging techniques, we can be very cost effective. This information may help patients at risk or with known CAD to obtain insurance coverage to prevent the disease as well as providing a more effective way of treating it.

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

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves lifestyle modifications and lipid-lowering drugs, it's possible that some medication adjustments might be needed. Please consult with the study team for specific guidance.

Is the lifestyle modification program for coronary artery disease safe for humans?

The lifestyle modification program for coronary artery disease has been shown to be safe, with low rates of illness and death among participants. It also improved quality of life and health markers like blood lipids and exercise capacity. ^{1 2 3 4 5}

How is the Comprehensive therapy program for risk factor modification different from other treatments for coronary artery disease?

This treatment is unique because it focuses on intensive lifestyle changes, such as diet, exercise, and stress management, rather than relying solely on medication. It aims to address multiple risk factors simultaneously, which can lead to significant improvements in heart health and quality of life. ^{4 5 6 7 8}

What data supports the effectiveness of the treatment Comprehensive therapy program for risk factor modification for coronary artery disease?

Research shows that intensive lifestyle modification programs can significantly improve risk factors for coronary artery disease, such as blood lipids and exercise capacity, and enhance quality of life. These programs have been effective in both preventing and managing coronary artery disease by promoting healthy lifestyle changes like better diet, regular exercise, and smoking cessation. ^{4 5 9 10 11}

Who Is on the Research Team?

K. Lance Gould, MD

Principal Investigator

University of Texas Medical Health Science Center at Houston

Are You a Good Fit for This Trial?

The Century Trial is for men and women over 40 who may have or are at high risk of coronary artery disease (CAD). They should be able to consent, need stress perfusion testing, and could have diabetes, recent smoking history, unhealthy cholesterol levels, hypertension, or a family history of CAD. Excluded are those with severe kidney issues, recent heart attacks or strokes, morbid obesity, other major illnesses affecting survival chances or participation ability.

Inclusion Criteria

I am 40 years old or older.

You need to have a stress perfusion test for a specific medical reason.

I have risk factors like diabetes, smoking, high LDL, low HDL, hypertension, or a family history of early heart disease.

Exclusion Criteria

My heart's pumping ability is severely reduced.

I have experienced fast and irregular heartbeats.

I have a severe disability that won't improve in 6 months, preventing me from exercising.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline myocardial PET perfusion study, electrocardiogram, exercise treadmill stress test, diet review, and blood work

1-2 weeks

1 visit (in-person)

Treatment

Participants receive either PET guided comprehensive therapy or standard medical management

5 years

Annual visits (in-person) for standard care; 5 visits in the first year and semiannual visits thereafter for comprehensive care

Follow-up

Participants are monitored for cardiovascular events and risk score modification

5 years

Annual visits (in-person) and yearly telephone/mail follow-up

Extended Follow-up

Additional 5-year follow-up for comprehensive management arm, with annual visits

5 years

Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Comprehensive therapy program for risk factor modification

Trial Overview This Phase III trial tests if a comprehensive lifestyle modification program plus lipid-lowering drugs can improve cardiovascular health better than standard care. It measures the impact on death rates and heart events by comparing two groups: one receiving PET scans with the new therapy regimen and another following current medical guidelines.

How Is the Trial Designed?

Group I: Intensive lifestyle modification Experimental Treatment 1 Intervention

P.E.T. guided comprehensive therapy program. The study intervention is Comprehensive therapy program for risk factor modification. The Comprehensive program of atherosclerotic risk factor modification involves treatment to target lipid levels, blood pressure and diabetes control, smoking cessation, very low fat diet and aerobic exercise program. This is in addition to standard current medical therapy as provided by primary physician. No experimental medications or procedures will be used.

Group II: Current standard of care Active Control 1 Intervention

Current standard of care medical management as provided by primary physician.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

In a study of 72 participants in a lifestyle modification program, those with elevated cardiovascular disease (CVD) risk factors but no clinical disease showed equal or greater improvements in heart health compared to those with existing CVD.

The results indicate that intensive lifestyle change programs can be effective for primary prevention of CVD, highlighting their importance for individuals at increased risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive lifestyle modification: impact on cardiovascular disease risk factors in subjects with and without clinical cardiovascular disease. Ellsworth, DL., O'Dowd, SC., Salami, B., et al.[2019]

A comprehensive lifestyle behavior change program for 292 participants with coronary artery disease led to significant improvements in health outcomes, including better blood lipids, increased exercise capacity, and reduced body mass index over a year of follow-up.

Participants also reported enhanced quality of life and positive changes in psychological factors like anger and hostility, indicating the program's effectiveness in both physical and mental health rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multifactorial evaluation of a program for lifestyle behavior change in rehabilitation and secondary prevention of coronary artery disease. Lisspers, J., Hofman-Bang, C., Nordlander, R., et al.[2019]

In an observational study of 722 coronary heart disease patients across 36 practices in Spain, community-oriented programs aimed at promoting healthy lifestyles did not show significant added value in cardiovascular risk management outcomes compared to practices without such programs.

While practices that implemented community programs had higher rates of patients receiving antihypertensives, antiplatelet therapy, and statins, these differences were not statistically significant, suggesting that these programs may not enhance the effectiveness of cardiovascular risk management for CHD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community programmes for coronary heart disease in Spanish primary care. Frigola-Capell, E., van Lieshout, J., Muñoz, MA., et al.[2017]

Citations

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

Intensive lifestyle modification: impact on cardiovascular disease risk factors in subjects with and without clinical cardiovascular disease. [2019]

2. Brazil pubmed.ncbi.nlm.nih.gov

Cardiovascular prevention in coronary heart disease patients: guidelines implementation in clinical practice. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Multifactorial evaluation of a program for lifestyle behavior change in rehabilitation and secondary prevention of coronary artery disease. [2019]

4. Ireland pubmed.ncbi.nlm.nih.gov

Effects of a lifestyle-related risk factor modification intervention on lifestyle changes among patients with coronary artery disease in Nepal. [2021]

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

The potential of lifestyle changes for improving the clinical outcome of patients with coronary heart disease: mechanisms of benefit and clinical results. [2019]

6. Brazil pubmed.ncbi.nlm.nih.gov

Efficacy of lifestyle change psychological intervention in coronary risk reduction. [2019]

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

Systematic review of randomised controlled trials of multiple risk factor interventions for preventing coronary heart disease. [2022]

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

Effectiveness of therapeutic lifestyle changes in patients with hypertension, hyperlipidemia, and/or hyperglycemia. [2006]

9. England pubmed.ncbi.nlm.nih.gov

Community programmes for coronary heart disease in Spanish primary care. [2017]

10. England pubmed.ncbi.nlm.nih.gov

Efficacy of multifactorial lifestyle interventions in patients with established cardiovascular diseases and high risk groups. [2012]

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

Effects of intensive multiple risk factor reduction on coronary atherosclerosis and clinical cardiac events in men and women with coronary artery disease. The Stanford Coronary Risk Intervention Project (SCRIP). [2019]