title: Identification of new biosignatures for clinical outcomes in stable coronary artery disease - The study protocol and initial observations of a prospective follow-up study in Taiwan.
abstract: Either classic or novel biomarkers have not been well investigated for clinical outcomes of coronary artery disease (CAD) in Asian people especially ethnic Chinese. We reported here a prospective national-based follow-up study that aims to elucidate the clinical profiles and to identify the new biosignatures (especially the non-lipid profile and inflammatory biomakers) for future clinical outcomes in a sizable cohort of stable CAD patients in Taiwan.
  
  
  
  A total of 2500 CAD patients under stable condition after successful percutaneous coronary intervention will be enrolled for clinical data collection and blood/urine sampling in northern, southern, western, or eastern part of Taiwan between 2012 and 2017. They will be regularly followed up at least annually for 5 years to assess all cause deaths, hard clinical events (including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke), and total cardiovascular events (including hard events, unplanned revascularization procedures, unplanned hospitalization for refractory or unstable angina, and for other causes such as stroke, transient ischemic attack, heart failure, or peripheral arterial occlusive disease). The classic and newly defined biosignatures will be compared in patients with and without clinical events during follow-up. The novel biomarkers will be identified via metabolomics analyses. Additionally, psychological personality and lifestyle data will be incorporated to explore the new dimensional views of the complex mechanisms of the disease. Till December 2014, the initial 1663 patients have been successfully enrolled. Among them, 85.93% are male; 36.22% have type 2 diabetes; 64.82% have hypertension; 56.04% are smokers and 20.44% have a family history of CAD. Their lipid profiles are under contemporary medical control with a mean plasma total cholesterol level of 163.51 ± 36.99 mg/dL and a mean low-density lipoprotein cholesterol level of 95.21 ± 29.98 mg/dL.
  
  
  
  This nationwide study has successfully started to update the contemporary information and to investigate the potential predictors for clinical outcomes of stable CAD patients in Taiwan. The identification of new biomarkers, lifestyle and psychological personality may help to elucidate the complex mechanisms and provide the novel rational to the individual treatment strategies in Asian especially ethnic Chinese patients with CAD.
authors.affiliation: Institute of Clinical Medicine and Cardiovascular Research Center, National Yang-Ming University, Taipei, Taiwan.|Heath Care and Management Center, Taipei Veterans General Hospital, Taipei, Taiwan.|Divison of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
authors.forename: Hsin-Bang
authors.initials: HB
authors.lastname: Leu
authors.affiliation: Division of Cardiology, Heart Center, Cheng-Hsin General Hospital, and School of Medicine, National Yang-Ming University, Taipei, Taiwan.
authors.forename: Wei-Hsian
authors.initials: WH
authors.lastname: Yin
authors.affiliation: Department of Medical Imaging and Radiological Sciences, I-Shou University, Kaohsiung, Taiwan.|Division of Cardiology, Department of Internal Medicine, E-Da Hospital, Kaohsiung, Taiwan.
authors.forename: Wei-Kung
authors.initials: WK
authors.lastname: Tseng
authors.affiliation: Cardiology Division of Cardiovascular Medical Center and Department of Nuclear Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan.
authors.forename: Yen-Wen
authors.initials: YW
authors.lastname: Wu
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Kaohsiung Medical University Hospital and Kaohsiung Medical University, Kaohsiung, Taiwan.
authors.forename: Tsung-Hsien
authors.initials: TH
authors.lastname: Lin
authors.affiliation: Mackay Memorial Hospital, Mackay Medical College, New Taipei City, Taiwan.
authors.forename: Hung-I
authors.initials: HI
authors.lastname: Yeh
authors.affiliation: Division of Cardiology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.|Graduate Institute of Clinical Medical Science, China Medical University, Taichung, Taiwan.
authors.forename: Kuan-Cheng
authors.initials: KC
authors.lastname: Chang
authors.affiliation: Department of Cardiology, Buddhist Tzu-Chi General Hospital, Tzu-Chi University, Hualien, Taiwan.
authors.forename: Ji-Hung
authors.initials: JH
authors.lastname: Wang
authors.affiliation: Division of Cardiology, Department of Internal Medicine, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.|Department of Primary Care Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan.
authors.forename: Chau-Chung
authors.initials: CC
authors.lastname: Wu
authors.affiliation: Institute of Clinical Medicine and Cardiovascular Research Center, National Yang-Ming University, Taipei, Taiwan. jwchen@vghtpe.gov.tw.|Divison of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. jwchen@vghtpe.gov.tw.|Institute of Pharmacology, National Yang-Ming University School of Medicine, Taipei, Taiwan. jwchen@vghtpe.gov.tw.|Division of Clinical Research, Department of Medical Research, Taipei Veterans General Hospital, 201, Section 2, Shih-Pai Road, Taipei, 112, Taiwan, R.O.C.. jwchen@vghtpe.gov.tw.
authors.forename: Jaw-Wen
authors.initials: JW
authors.lastname: Chen
mesh_terms: D000368:Aged; D044466:Asian People / Q000523:psychology; D015415:Biomarkers / Q000097:blood* / Q000652:urine*; D002681:China / Q000208:ethnology; D002985:Clinical Protocols; D003324:Coronary Artery Disease / Q000175:diagnosis* / Q000208:ethnology / Q000523:psychology / Q000628:therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008019:Life Style / Q000208:ethnology; D008297:Male; D055432:Metabolomics / Q000379:methods*; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention; D010551:Personality; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012107:Research Design; D012307:Risk Factors; D013624:Taiwan / Q000453:epidemiology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers
keywords: Asian; Biomarkers; Biosignaturs; Chinese; Coronary artery disease; Lipid; Outcome