Century Trial, a Randomized Lifestyle Modification Study for Management of Stable Coronary Artery Disease

Running, not enrolling · Not applicable

Conditions studied: Cardiovascular Disease, Atherosclerosis, Coronary Artery Disease, Coronary Stenosis

In brief

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.

Key facts

Study ID

NCT00756379

Run by

The University of Texas Health Science Center, Houston

People needed

1085

Starts

2009-03-11

Expected to finish

2027-05-31

Last updated by the study team

2026-03-05

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 disease OR atherosclerotic peripheral vascular disease (APVD) as defined by ankle-brachial index below 0.9 and/or by abnormal duplex ultrasound, CT angiography, magnetic resonance angiography (MRA) or conventional invasive angiogram or previous revascularization procedure.
• Framingham's high risk criteria refers to presence of diabetes mellitus with the limitation described above (c) or 10 year absolute Coronary Heart Disease(CHD)risk of >or= 20% (see tables Appendix A).
• Chest pain is defined as Typical Angina if Exertional + Retrosternal + relieved with rest or sublingual nitroglycerin (NTG) , Atypical angina if only two of the above criteria are present and Non-anginal if one or none of the above are present.

You may not qualify if…

• Age <40
• Low pretest likelihood of CAD (= not meeting the above criteria)
• Unstable angina high risk (dynamic ST-Twave ECG changes and/or elevated troponin)
• Recent MI (<4 weeks)
• Recent stroke (<4 weeks)
• CABG or percutaneous coronary intervention (PCI) within the last 6 months
• Severe renal dysfunction as defined by creatinine > 2.0 mg/dl
• Active liver disease or hepatic dysfunction, AST or ALT > x 2 the upper limit of normal (ULN)
• Concomitant valvular heart disease
• Left ventricular ejection fraction (LVEF) <30%
• Severe systemic hypertension defined as systolic blood pressure (SBP) > 200 mmHg
• Symptomatic sustained or non-sustained ventricular tachycardia
• Morbid Obesity defined by Body Mass Index > 35
• Sever disability to prevent therapeutic exercise not expected to resolve within 6 months
• Major non-cardiac co-morbidity limiting survival or social situation/condition that in the opinion of the investigator will preclude the patient from participation in the study follow-up.
• Concurrent or prior (within last 30 days) participation in other research studies using investigational drugs or devices.

Where it is running

• Weatherhead PET Center, Memorial Hermann Hospital TMC — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.