Status:
ACTIVE_NOT_RECRUITING
Century Trial, a Randomized Lifestyle Modification Study for Management of Stable Coronary Artery Disease
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Cardiovascular Disease
Atherosclerosis
Eligibility:
All Genders
40+ years
Phase:
NA
Brief 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-tr...
Detailed 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 heal...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 11 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2027
Estimated Enrollment :
1085 Patients enrolled
Trial Details
Trial ID
NCT00756379
Start Date
March 11 2009
End Date
May 31 2027
Last Update
December 6 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Weatherhead PET Center, Memorial Hermann Hospital TMC
Houston, Texas, United States, 77030