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

Prior treatment

• Concomitant valvular heart disease
• Concurrent or prior (within last 30 days) participation in other research studies using investigational drugs or devices.

Other illness

• Unstable angina high risk (dynamic ST-Twave ECG changes and/or elevated troponin)
• Recent stroke (<4 weeks)
• Severe systemic hypertension defined as systolic blood pressure (SBP) > 200 mmHg
• 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.

Lab values

• 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)
• Left ventricular ejection fraction (LVEF) <30%

Age

• Age <40

Other

• Low pretest likelihood of CAD (= not meeting the above criteria)
• Recent MI (<4 weeks)
• CABG or percutaneous coronary intervention (PCI) within the last 6 months
• 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

• 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.