Century Trial, a Randomized Lifestyle Modification Study for Management of Stable Coronary Artery Disease
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 9/29/2018 |
| Start Date: | March 11, 2009 |
| End Date: | March 2022 |
Randomized Trial of Comprehensive Lifestyle Modifications, Optimal Pharmacological Treatment and PET Imaging for Detection and Management of Stable Coronary Artery Disease
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.
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.
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 health care and more people being deprived of its benefits (Sultz 2004,
Bodenheimer 2002).
In the field of coronary artery disease (CAD) are several non-invasive imaging techniques for
diagnostic and risk stratification purposes such as echocardiography, perfusion imaging
(cardiac stress SPECT - single photon emission computed tomography - and stress PET -
positron emission tomography), non-invasive cardiac computed tomography angiography (CTA) and
combined perfusion-anatomy (PET-CT) studies. There are an estimated 40 million noninvasive
cardiac tests performed each year (Mark DB 2003). For echocardiography and SPECT imaging,
reimbursement from Medicare encompasses approximately 30% of all payments, totaling over $1
billion in the year 2000 (ACC 2003). There are, however, basic questions about cardiovascular
imaging techniques that need to be addressed: how does technology benefit the patient? It is
worth the cost? Is treatment plan enhanced? Is outcome better? Data are necessary for
addressing these questions and if appropriate for acceptance among practicing physicians,
patients and third party insurers.
The relevance of the proposed study, the CENTURY trial, lies in its original design, testing
the impact of stress perfusion imaging by PET coupled with two different intensities of
clinical management strategies (standard or comprehensive respectively). This study will
examine post-test resource utilization and reduction of cardiovascular risk in patients with
known disease or at high risk for CAD.
There will be a total of 1300 men and women enrolled with approximately 650 subjects
randomized to one of two treatment arms. Eligible patients must have clinical indications for
stress perfusion testing.
Following confirmation of eligibility and provision of signed informed consent, patients will
be randomized to one of the two possible treatment strategies. At time of randomization
patients will be assigned to "PET guided + comprehensive" versus "standard medical
treatment."
Patients of both groups will have a baseline myocardial PET perfusion study to quantify the
blood flow to the heart muscle, an electrocardiogram, an exercise treadmill stress test to
assess exercise tolerance (fitness), a thorough review of the quality of their diet and a
complete blood work covering individual lipid profiles. These tests and assessments will be
repeated at 2 years and at 5 years.
In addition subjects assigned to the standard medical management arm will be managed by
current standard care provided by their primary referring physician and will be asked to come
for clinic study visits annually for 5 years to document their medical and lifestyle
management. The PET scan results will be blinded until the end of the study to the standard
of care management group.
Subjects enrolled in the comprehensive medical management arm will have the support of a team
of professionals focusing on atherosclerotic risk factor modification that involves
recommended treatment to target lipid levels, blood pressure and diabetes control, smoking
cessation, very low fat diet and aerobic exercise program. This is in addition to standard
current medical therapy as provided by the primary referring physician.
No experimental medication or procedures will be used. Clinic visits for subject's education
and consulting in the comprehensive program will be performed five times during the first
year and semiannually thereafter.
favor illness intervention rather than primary and secondary prevention have resulted in
rising costs of health care and more people being deprived of its benefits (Sultz 2004,
Bodenheimer 2002).
In the field of coronary artery disease (CAD) are several non-invasive imaging techniques for
diagnostic and risk stratification purposes such as echocardiography, perfusion imaging
(cardiac stress SPECT - single photon emission computed tomography - and stress PET -
positron emission tomography), non-invasive cardiac computed tomography angiography (CTA) and
combined perfusion-anatomy (PET-CT) studies. There are an estimated 40 million noninvasive
cardiac tests performed each year (Mark DB 2003). For echocardiography and SPECT imaging,
reimbursement from Medicare encompasses approximately 30% of all payments, totaling over $1
billion in the year 2000 (ACC 2003). There are, however, basic questions about cardiovascular
imaging techniques that need to be addressed: how does technology benefit the patient? It is
worth the cost? Is treatment plan enhanced? Is outcome better? Data are necessary for
addressing these questions and if appropriate for acceptance among practicing physicians,
patients and third party insurers.
The relevance of the proposed study, the CENTURY trial, lies in its original design, testing
the impact of stress perfusion imaging by PET coupled with two different intensities of
clinical management strategies (standard or comprehensive respectively). This study will
examine post-test resource utilization and reduction of cardiovascular risk in patients with
known disease or at high risk for CAD.
There will be a total of 1300 men and women enrolled with approximately 650 subjects
randomized to one of two treatment arms. Eligible patients must have clinical indications for
stress perfusion testing.
Following confirmation of eligibility and provision of signed informed consent, patients will
be randomized to one of the two possible treatment strategies. At time of randomization
patients will be assigned to "PET guided + comprehensive" versus "standard medical
treatment."
Patients of both groups will have a baseline myocardial PET perfusion study to quantify the
blood flow to the heart muscle, an electrocardiogram, an exercise treadmill stress test to
assess exercise tolerance (fitness), a thorough review of the quality of their diet and a
complete blood work covering individual lipid profiles. These tests and assessments will be
repeated at 2 years and at 5 years.
In addition subjects assigned to the standard medical management arm will be managed by
current standard care provided by their primary referring physician and will be asked to come
for clinic study visits annually for 5 years to document their medical and lifestyle
management. The PET scan results will be blinded until the end of the study to the standard
of care management group.
Subjects enrolled in the comprehensive medical management arm will have the support of a team
of professionals focusing on atherosclerotic risk factor modification that involves
recommended treatment to target lipid levels, blood pressure and diabetes control, smoking
cessation, very low fat diet and aerobic exercise program. This is in addition to standard
current medical therapy as provided by the primary referring physician.
No experimental medication or procedures will be used. Clinic visits for subject's education
and consulting in the comprehensive program will be performed five times during the first
year and semiannually thereafter.
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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