Century Trial, a Randomized Lifestyle Modification Study for Management of Stable Coronary Artery Disease
The Century Trial is a single center Phase III randomized study sponsored by the Albert Weatherhead III Foundation and conducted by Dr. Stefano Sdringola and 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.
Coronary Artery Disease
Other: Comprehensive therapy program for risk factor modification
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Randomized Trial of Comprehensive Lifestyle Modifications, Optimal Pharmacological Treatment and PET Imaging for Detection and Management of Stable Coronary Artery Disease|
- 1.Clinical Endpoints-Average Risk Score modification during 5 year follow-up and major cardiovascular clinical events of death and non-fatal myocardial infarction. [ Time Frame: 2 years and 5 years ] [ Designated as safety issue: No ]
- 2. Secondary outcome measures are major events consisting of death, non-fatal MI, stroke, and revascularization procedures. [ Time Frame: 2 years and 5 years ] [ Designated as safety issue: No ]
- Comprehensive economic analysis to compare total cost and health outcomes of treating patients at risk or with established CAD [ Time Frame: 2 and 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||January 2019|
|Estimated Primary Completion Date:||January 2019 (Final data collection date for primary outcome measure)|
Experimental: Intensive lifestyle modification
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.
Other: Comprehensive therapy program for risk factor modification
Patients enrolled in the comprehensive therapy arm will have a baseline myocardial perfusion PET and the support of a team of professionals aiming to modify and minimize all the known CAD risk factors. During the 5 year follow-up they will be educated and guided toward a healthy lifestyle by a dietician, an exercise physiologist/cardiovascular physician specialist.
No Intervention: Current standard of care
Current standard of care medical management as provided by primary physician.
Advances in diagnostic imaging with expensive technologies and reimbursement policies that favor illness intervention rather than primary and secondary prevention have resulted in rising costs of health care and more people being deprived of its benefits (Sultz 2004, Bodenheimer 2002).
In the field of coronary artery disease (CAD) are several non-invasive imaging techniques for diagnostic and risk stratification purposes such as echocardiography, perfusion imaging (cardiac stress SPECT - single photon emission computed tomography - and stress PET - positron emission tomography), non-invasive cardiac computed tomography angiography (CTA) and combined perfusion-anatomy (PET-CT) studies. There are an estimated 40 million noninvasive cardiac tests performed each year (Mark DB 2003). For echocardiography and SPECT imaging, reimbursement from Medicare encompasses approximately 30% of all payments, totaling over $1 billion in the year 2000 (ACC 2003). There are, however, basic questions about cardiovascular imaging techniques that need to be addressed: how does technology benefit the patient? It is worth the cost? Is treatment plan enhanced? Is outcome better? Data are necessary for addressing these questions and if appropriate for acceptance among practicing physicians, patients and third party insurers.
The relevance of the proposed study, the CENTURY trial, lies in its original design, testing the impact of stress perfusion imaging by PET coupled with two different intensities of clinical management strategies (standard or comprehensive respectively). This study will examine post-test resource utilization and reduction of cardiovascular risk in patients with known disease or at high risk for CAD.
There will be a total of 1300 men and women enrolled with approximately 650 subjects randomized to one of two treatment arms. Eligible patients must have clinical indications for stress perfusion testing.
Following confirmation of eligibility and provision of signed informed consent, patients will be randomized to one of the two possible treatment strategies. At time of randomization patients will be assigned to "PET guided + comprehensive" versus "standard medical treatment."
Patients of both groups will have a baseline myocardial PET perfusion study to quantify the blood flow to the heart muscle, an electrocardiogram, an exercise treadmill stress test to assess exercise tolerance (fitness), a thorough review of the quality of their diet and a complete blood work covering individual lipid profiles. These tests and assessments will be repeated at 2 years and at 5 years.
In addition subjects assigned to the standard medical management arm will be managed by current standard care provided by their primary referring physician and will be asked to come for clinic study visits annually for 5 years to document their medical and lifestyle management. The PET scan results will be blinded until the end of the study to the standard of care management group.
Subjects enrolled in the comprehensive medical management arm will have the support of a team of professionals focusing on atherosclerotic risk factor modification that involves recommended 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 the primary referring physician.
No experimental medication or procedures will be used. Clinic visits for subject's education and consulting in the comprehensive program will be performed five times during the first year and semiannually thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756379
|Contact: Catey V Carter, RNfirstname.lastname@example.org|
|Contact: Mary P Haynie, RN, MBAemail@example.com|
|United States, Texas|
|Weatherhead PET Center, Memorial Hermann Hospital TMC||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Stefano Sdringola, MD||University of Texas Medical School at Houston|
|Principal Investigator:||K. Lance Gould, MD||University of Texas Medical Health Science Center at Houston|