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

NCT00756379 | Active Not Recruiting

• 1 other identifier: HSC-MS-08-0312
• Study Type: interventional
• Target: 1,085
• Locations: 1 country
• Sites: 1

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-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.

Conditions

Cardiovascular Disease; Atherosclerosis; Coronary Artery Disease; Coronary Stenosis

Keywords

Cardiovascular disease; Atherosclerosis; Coronary artery disease; Coronary perfusion defect; Absolute coronary flow; Lifestyle management; Cardiovascular rehabilitation; Cardiovascular dietary guidelines

Outcome Measures

Primary Outcomes (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.

  2 years, 5 years and 10 years

Secondary Outcomes (1)

• 2. Secondary outcome

  2 years, 5 years and 10 years

Other Outcomes (1)

• Comprehensive economic analysis

  2 years, 5 years and 10 years

Study Arms (2)

Intensive lifestyle modification

EXPERIMENTAL

P.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.

Other: Comprehensive therapy program for risk factor modification

Current standard of care

NO INTERVENTION

Current standard of care medical management as provided by primary physician.

Interventions

Comprehensive therapy program for risk factor modification OTHER

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.

Also known as: Coronary artery disease, Lifestyle management, Atherosclerosis, Cardiovascular disease management, Cardiovascular disease reversal

Intensive lifestyle modification

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Weatherhead PET Center, Memorial Hermann Hospital TMC

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 40439159 DERIVED

• 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.

  PMID: 33762179 DERIVED

Related Links

• For more information about cardiac PET imaging

MeSH Terms

Conditions

Cardiovascular Diseases; Atherosclerosis; Coronary Artery Disease; Coronary Stenosis

Interventions

JCAD protein, mouse

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Study Officials

• K. Lance Gould, MD

  University of Texas Medical Health Science Center at Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Internal Medicine, Cardiology

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2008
• First Posted: September 22, 2008
• Study Start: March 11, 2009
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)