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Cardiovascular DiseaseCenturyNCT00756379

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

A study testing Comprehensive therapy program for risk factor modification in people with Cardiovascular Disease and Atherosclerosis, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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-treatment regimen of PET + comprehensive program of lifestyle modification and lipid lowering drugs to target lipid level… Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Comprehensive therapy program for risk factor modification
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,085 participants
Where
1 siteUnited States
Study dates
11 Mar 2009to 31 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Weatherhead PET Center, Memorial Hermann Hospital TMC

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: 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.

Read the 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 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.

At the end of the first 5 years, patients in the "comprehensive" medical management arm will be offered an additional 5-year follow-up at the current study location once a year.

The extended follow-up on cardiovascular or other adverse events for the "current standard of care" group will be based on yearly telephone or mail follow-up.

Both groups will have a full consultation visit, exercise treadmill and dipyridamole PET scan at the end of the total 10 years follow-up, replicating the current initial 5-year follow-up visit protocol.

Being tested
Comprehensive therapy program for risk factor modification
Keywords
Cardiovascular disease, Atherosclerosis, Coronary artery disease, Coronary perfusion defect, Absolute coronary flow, Lifestyle management, Cardiovascular rehabilitation, Cardiovascular dietary guidelines
Medical subject headings
Cardiovascular Diseases, Atherosclerosis, Coronary Artery Disease, Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comprehensive therapy program for risk factor modificationOther

    Also called Coronary artery disease, Lifestyle management, Atherosclerosis, Cardiovascular disease management

    Patients enrolled in the comprehensive therapy arm will have a baseline myocardial perfusion PET and the support of a team of professionals aiming to modify and minimize all the known CAD risk factors. During the 5 year follow-up they will be educated and guided toward a healthy lifestyle by a dietician, an exercise physiologist/cardiovascular physician specialist.

Study groups in NCT00756379
Study groupRoleWhat they receive
Intensive lifestyle modificationExperimentalP.E.T. guided comprehensive therapy program. The study intervention is Comprehensive therapy program for risk factor modification. The Comprehensive program of atherosclerotic risk factor modification involves 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 primary physician. No experimental medications or procedures will be used.
Receives: Other: Comprehensive therapy program for risk factor modification
Current standard of careNo interventionCurrent standard of care medical management as provided by primary physician.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1.Clinical Endpoints-

    Average Risk Score modification during 5 year follow-up and major cardiovascular clinical events of death and non-fatal myocardial infarction.

    Measured: 2 years, 5 years and 10 years

Secondary outcomes (1)
  1. 2. Secondary outcome

    These measures are major events consisting of death, non-fatal MI, stroke, and revascularization procedures.

    Measured: 2 years, 5 years and 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2008 (estimated)
  2. Study start11 Mar 2009
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Study Intervention: PET diagnostic imaging offered in addition to current standard of care for the detection of coronary atherosclerosis. Comprehensive program of atherosclerotic risk factor modification, involving treatment to target lipid levels, blood pressure and diabetes control, smoking cessation, very low fat diet and aerobic exercise program. This is addition to standard current medical therapy as provided by primary referring physician. No experimental medication or procedure will be used. Clinic visits for patients education and consulting in the comprehensive program will be performed five times during the first year and semiannually thereafter.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,085 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00756379
Sponsor's protocol ID
HSC-MS-08-0312
Acronym
Century
Status last verified
Mar 2026
First submitted
18 Sep 2008
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Gould KL, Johnson NP, Roby AE, Kirkeeide RL, Bui LP, Patel MB, Kitkungvan D, Haynie MP, Hood SM, Mendoza PM, Rickman AM, Pipitone TH, Garner KP, Sander K, Harmon L, Chen LW, Nguyen T, Lai D, Li R, Sdringola S, Narula N, Narula J, McPherson DD. Coronary Blood Flow in Women From the CENTURY Trial: Potential Mechanisms for Sex Differences in Coronary Disease. JACC Cardiovasc Imaging. 2026 Sep 10:S1936-878X(26)00416-X. doi: 10.1016/j.jcmg.2026.07.017. Online ahead of print.

    PubMed 42730743
  • Gould KL, Johson NP. Quantitative PET coronary flow capacity and comprehensive management of chronic CAD: Lessons from the randomized CENTURY trial. Atherosclerosis. 2026 Aug;419:120831. doi: 10.1016/j.atherosclerosis.2026.120831. Epub 2026 Jun 30.

    PubMed 42435732
  • Gould KL, Johnson NP, Roby AE, Kirkeeide R, Haynie M, Nguyen T, Bui L, Patel MB, Kitkungvan D, Mendoza P, Lai D, Li R, Sdringola S, McPherson D, Narula J. Optimal medical care and coronary flow capacity-guided myocardial revascularization vs usual care for chronic coronary artery disease: the CENTURY trial. Eur Heart J. 2025 Sep 2;46(33):3273-3286. doi: 10.1093/eurheartj/ehaf356.

    PubMed 40439159
  • Kitkungvan D, Johnson NP, Kirkeeide R, Haynie M, Carter C, Patel MB, Bui L, Madjid M, Mendoza P, Roby AE, Hood S, Zhu H, Lai D, Sdringola S, Gould KL. Design and rationale of the randomized trial of comprehensive lifestyle modification, optimal pharmacological treatment and utilizing PET imaging for quantifying and managing stable coronary artery disease (the CENTURY study). Am Heart J. 2021 Jul;237:135-146. doi: 10.1016/j.ahj.2021.03.012. Epub 2021 Mar 21.

    PubMed 33762179

Questions about this trial

What is this clinical trial studying?

A study testing Comprehensive therapy program for risk factor modification in people with Cardiovascular Disease and Atherosclerosis, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1.Clinical Endpoints- (time frame: 2 years, 5 years and 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00756379, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026; AzTrials last refreshed its copy on 4 Nov 2026.

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