Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00756379 |
| Other study ID # |
HSC-MS-08-0312 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 11, 2009 |
| Est. completion date |
May 31, 2027 |
Study information
| Verified date |
September 2023 |
| Source |
The University of Texas Health Science Center, Houston |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
At the end of the first 5 years, patients in the "comprehensive" medical management arm will
be offered an additional 5-year follow-up at the current study location once a year.
The extended follow-up on cardiovascular or other adverse events for the "current standard of
care" group will be based on yearly telephone or mail follow-up.
Both groups will have a full consultation visit, exercise treadmill and dipyridamole PET scan
at the end of the total 10 years follow-up, replicating the current initial 5-year follow-up
visit protocol.
