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.
I am mentally capable of understanding and signing a consent form.
I am being tested for heart issues due to symptoms, a history of heart disease, or past heart surgery.
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.
I am younger than 40 years old.
I have unstable angina with specific heart test changes.
My kidney function is poor, with creatinine levels above 2.0 mg/dl.
I have a heart valve condition.
My liver functions are within normal limits.
Treatment Details
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.
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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Weatherhead PET Center, Memorial Hermann Hospital TMCHouston, TX
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Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor