Century Trial, a Randomized Lifestyle Modification Study for Management of Stable Coronary Artery… (NCT00756379) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Century Trial, a Randomized Lifestyle Modification Study for Management of Stable Coronary Artery Disease
United States1,085 participantsStarted 2009-03-11
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects must be competent to provide written informed consent.
* Subjects must sign an Institutional Review Board (IRB) approved Informed Consent Form (ICF) and HIPAA Authorization prior to the initiation of any study procedures.
* Men and women age ≥40
\_ Indication for stress perfusion testing
* Appropriate Indications for stress perfusion testing:
* Suspected CAD:
* Men with any chest pain syndrome and two other risk factors
* Women \>50 years old with any chest pain syndrome and two other risk factors
* Asymptomatic men and women \>50 years with at least three other risk factors\* or Coronary Calcium Agatston score \>400.
* Diabetic men and women and two other risk factors
* Documented known CAD:
* Men and women asymptomatic or stable symptoms and known CAD by abnormal catheterization or prior SPECT without revascularization after \>2 years to evaluate worsening disease or
* Men and women with worsening symptoms and known CAD by abnormal catheterization or prior SPECT/PET without revascularization
* Men and women with chest pain syndrome and previous revascularization
* Asymptomatic men and women \>5 years after coronary artery bypass graft surgery (CABG) or \>2 years after PCI
* Risk factors: Diabetes, Current or recent cigarette smoking (within the last 12 months), LDL\>130, low HDL \<50 women, HDL \<45 men, history of metabolic syndrome, hypertension (SPB\>140), family history of premature (\<60 year) CAD, Atherosclerotic carotid artery di…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1.Clinical Endpoints-
Timeframe: 2 years, 5 years and 10 years
Trial details
NCT IDNCT00756379
SponsorThe University of Texas Health Science Center, Houston