TY - JOUR
T1 - 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)
AU - Kitkungvan, Danai
AU - Johnson, Nils P.
AU - Kirkeeide, Richard
AU - Haynie, Mary
AU - Carter, Catharine
AU - Patel, Monica B.
AU - Bui, Linh
AU - Madjid, Mohammad
AU - Mendoza, Patricia
AU - Roby, Amanda E.
AU - Hood, Susan
AU - Zhu, Hongjian
AU - Lai, Dejian
AU - Sdringola, Stefano
AU - Gould, Kenneth Lance
N1 - Funding Information:
The CENTURY study (NCT00756379) is a privately sponsored randomized single-center clinical trial at the University of Texas Health Science Center at Houston, McGovern Medical School, Houston, Texas. The financial support for the trial derived from a non-commercial, philantrophic, charitable funding particularly the Weatherhead Foundation and the Weatherhead Endowment at the Unversity of Texas Health Science Center at Houston, McGovern Medical School. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper and its final contents. The study was approved by the institutional review board at the University of Texas Health Science Center at Houston, McGovern Medical School, and all participants signed informed consent to participate in the study.
Funding Information:
Research supported by internal funds of the Weatherhead PET Center. No authors have a relationship with industry related to this manuscript. NPJ received internal funding from Weatherhead PET Center for Preventing and Reversing Atherosclerosis and research support from St. Jude Medical (for NCT02184117 ) and Volcano/Philips Corporation (for NCT02328820 ). KLG received internal funding from the Weatherhead PET Center and is the 510(k) applicant for FDA approved HeartSee K171303 PET software. To avoid any conflict of interest, KLG assigned any royalties arising from PET software to UT for research or student scholarships.
Publisher Copyright:
© 2021 Elsevier Inc.
PY - 2021/7
Y1 - 2021/7
N2 - Background: The literature reports no randomized trial in chronic coronary artery disease (CAD) of a comprehensive management strategy integrating intense lifestyle management, maximal medical treatment to specific goals and high precision quantitative cardiac positron emission tomography (PET) for identifying high mortality risk patients needing essential invasive procedures. We hypothesize that this comprehensive strategy achieves greater risk factor reduction, lower major adverse cardiovascular events and fewer invasive procedures than standard practice. Methods: The CENTURY Study (NCT00756379) is a randomized-controlled-trial study in patients with stable or at high risk for CAD. Patients are randomized to standard of care (Standard group) or intense comprehensive lifestyle-medical treatment to targets and PET guided interventions (Comprehensive group). Comprehensive Group patients are regularly consulted by the CENTURY team implementing diet/lifestyle/exercise program and medical treatment to target risk modification. Cardiac PET at baseline, 24-, and 60-months quantify the physiologic severity of CAD and guide interventions in the Comprehensive group while patients and referring physicians of the Standard group are blinded to PET results. The primary end-point is the CENTURY risk score reduction during 5 years follow-up. The secondary endpoint is a composite of death, non-fatal myocardial infarction, stroke, and coronary revascularization. Conclusions: The CENTURY Study is the first study in stable CAD to test the incremental benefit of a comprehensive strategy integrating intense lifestyle modification, medical treatment to specific goals, and high-precision quantitative myocardial perfusion imaging to guide revascularization. A total of 1028 patients have been randomized, and the 5 years follow-up will conclude in 2022.
AB - Background: The literature reports no randomized trial in chronic coronary artery disease (CAD) of a comprehensive management strategy integrating intense lifestyle management, maximal medical treatment to specific goals and high precision quantitative cardiac positron emission tomography (PET) for identifying high mortality risk patients needing essential invasive procedures. We hypothesize that this comprehensive strategy achieves greater risk factor reduction, lower major adverse cardiovascular events and fewer invasive procedures than standard practice. Methods: The CENTURY Study (NCT00756379) is a randomized-controlled-trial study in patients with stable or at high risk for CAD. Patients are randomized to standard of care (Standard group) or intense comprehensive lifestyle-medical treatment to targets and PET guided interventions (Comprehensive group). Comprehensive Group patients are regularly consulted by the CENTURY team implementing diet/lifestyle/exercise program and medical treatment to target risk modification. Cardiac PET at baseline, 24-, and 60-months quantify the physiologic severity of CAD and guide interventions in the Comprehensive group while patients and referring physicians of the Standard group are blinded to PET results. The primary end-point is the CENTURY risk score reduction during 5 years follow-up. The secondary endpoint is a composite of death, non-fatal myocardial infarction, stroke, and coronary revascularization. Conclusions: The CENTURY Study is the first study in stable CAD to test the incremental benefit of a comprehensive strategy integrating intense lifestyle modification, medical treatment to specific goals, and high-precision quantitative myocardial perfusion imaging to guide revascularization. A total of 1028 patients have been randomized, and the 5 years follow-up will conclude in 2022.
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U2 - 10.1016/j.ahj.2021.03.012
DO - 10.1016/j.ahj.2021.03.012
M3 - Article
C2 - 33762179
AN - SCOPUS:85105318780
SN - 0002-8703
VL - 237
SP - 135
EP - 146
JO - American Heart Journal
JF - American Heart Journal
ER -