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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether combining lifestyle changes with standard medical care can manage coronary artery disease (CAD) more effectively than usual treatments alone. Participants will follow a comprehensive therapy program for risk factor modification, including a healthy diet, exercise, and medications to control cholesterol and blood pressure, alongside their regular medical care. The trial is ideal for individuals over 40 with chest pain and other risk factors like diabetes or a history of smoking. It aims to determine if these changes can lower the risk of heart-related issues and reduce healthcare costs. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve CAD management for many.

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.

What prior data suggests that this comprehensive therapy program for risk factor modification is safe?

Research has shown that the lifestyle program for heart disease is generally safe. In past studies, participants experienced low rates of illness and death. This program helps manage risk factors such as high cholesterol, high blood pressure, and diabetes. It includes quitting smoking, eating a low-fat diet, and exercising. The absence of experimental drugs or procedures reduces the chance of unexpected side effects. Overall, participants in those studies tolerated it well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on an intensive lifestyle modification approach for coronary artery disease, which is quite different from the usual reliance on medications alone. This comprehensive program targets multiple risk factors simultaneously, including cholesterol levels, blood pressure, diabetes, smoking, diet, and exercise, all guided by advanced P.E.T. imaging. Unlike the standard care that typically involves medication management, this trial emphasizes a holistic and proactive approach to reduce atherosclerosis risk. By combining these lifestyle changes with standard medical therapy, researchers hope to uncover significant improvements in patient outcomes.

What evidence suggests that this trial's comprehensive therapy program for risk factor modification could be effective for coronary artery disease?

Research has shown that lifestyle changes, such as improving diet and increasing exercise, greatly benefit heart health for people with coronary artery disease (CAD). In this trial, participants in the intensive lifestyle modification arm will follow a comprehensive therapy program for risk factor modification, which includes managing cholesterol, controlling blood pressure, quitting smoking, eating a very low-fat diet, and engaging in regular aerobic exercise. One study found that people who followed a detailed lifestyle change program developed healthier habits than those who did not. Another review highlights that these lifestyle changes, especially when combined with heart rehabilitation, lead to better recovery after heart attacks or procedures like stenting. These findings suggest that a well-rounded lifestyle program can significantly help those with CAD. ^{1 2 6 7 8}

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9190674/

Effects of intervention on lifestyle changes among coronary ... Overall, greater improvement in lifestyle habits was found in the intervention group compared with the control group at 6‐month follow‐up. Keywords: coronary ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11836608/

Pharmacotherapy, Lifestyle Modification, and Cardiac ... This review discusses pharmacotherapies and lifestyle interventions with a special focus on cardiac rehabilitation in the post-MI or PCI period to improve ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00756379

Century Trial, a Randomized Lifestyle Modification Study ... Century Trial, a Randomized Lifestyle Modification Study for Management of Stable Coronary Artery Disease (Century). ClinicalTrials.gov ID NCT00756379.

4. 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.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002870315003610

Trial Design Community-based comprehensive lifestyle ... The primary outcome at 12 months is the proportion of patients in whom at least 1 lifestyle risk factor is improved without deterioration in any of the other 2, ...

6. withpower.com withpower.com/trial/phase-coronary-artery-disease-2-2009-85809

Lifestyle Modification for Coronary Artery Disease (Century ... 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 ...

7. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/188274

Intensive Lifestyle Changes for Reversal of Coronary Heart ... The Lifestyle Heart Trial demonstrated that intensive lifestyle changes may lead to regression of coronary atherosclerosis after 1 year.

8. stacks.cdc.gov stacks.cdc.gov/view/cdc/27892/cdc_27892_DS1.pdf?

Effects of Lifestyle Modification Programs on Cardiac Risk ... Medicare conducted a payment demonstration from 2000 to 2008 to examine the effects of intense lifestyle modification programs in patients with ...