Can a supercharged lifestyle program beat standard heart care?
NCT ID NCT00756379
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a comprehensive program of lifestyle changes (diet, exercise, education) plus aggressive cholesterol-lowering drugs, guided by PET heart scans, can reduce heart attacks and deaths better than standard medical care. Over 1,000 adults with suspected or known coronary artery disease will be followed for 5 years. The goal is to see if this intensive approach improves heart health and is cost-effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- comprehensive lifestyle modification program (diet, exercise, education) plus lipid-lowering drugs
- What this could lead to
- If successful, this could show that an intensive lifestyle and medication program, guided by PET scans, reduces heart attacks and deaths more than standard care.
- What could go wrong
- This is a single-center study, so results may not apply everywhere. The program is intensive and may be hard for many people to follow long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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1,085 people
The number who actually took part.
- Started
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Mar 2009
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Weatherhead PET Center, Memorial Hermann Hospital TMC
Houston, Texas, 77030, United States
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