Lifestyle Modification for Coronary Artery Disease
(Century Trial)

Recruiting in Palo Alto (17 mi)

Overseen byK. Lance Gould, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: The University of Texas Health Science Center, Houston

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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.

See 4 more

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.

See 13 more

Treatment Details

Interventions

Comprehensive therapy program for risk factor modification (Behavioural Intervention)

Trial OverviewThis 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.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Intensive lifestyle modificationExperimental Treatment1 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 careActive Control1 Intervention

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