Care China-Diabetes

The Care China-Diabetes Registry A 12-month, Multi-centre, Prospective, Observational Registry Study to Investigate the Efficacy and Safety of CYPHER Select TM+ Sirolimus-eluting Coronary Stent Among Chinese Diabetic Patients With Coronary Artery Disease in Routine Clinical Practice

This multicenter, prospective, observational registry will assess efficacy and safety outcomes associated with percutaneous coronary intervention (PCI) with implantation of the CYPHER Select™+ Sirolimus-eluting Coronary Stents in Chinese diabetic patients with coronary artery disease in routine clinical practice.

Study Overview

• Status: Terminated
• Conditions: Cardiovascular Disease; Diabetes

Detailed Description

The study objective is to assess the incidences of major adverse cardiovascular events (MACE; defined as a composite of clinically driven target-lesion revascularization, cardiac death, any myocardial infarction, and stent thrombosis) at 12-month follow-up, and of stent thrombosis at 1-day, and 1- and 12-month follow-up. Pre-specified analyses will be performed among patient subpopulations according to level of glycemic control (HbA1c level < 6.5% or > 6.5%); reference vessel diameter by quantitative coronary angiography (< 2.5 mm and > 2.5 mm); and stented length (8-18 mm; 23-33 mm; and >33 mm). Quantitative coronary angiographic (QCA) analysis will be performed at the core lab of the China Cardiovascular Research Foundation for all pre- and post-index procedure angiograms and during the 12-month follow-up period for the pre- and post-reintervention procedures in those cases of clinically-driven PCI revascularization. Also, multivariable analyses will be conducted to investigate potential predictors of 12-month MACE rate in routine clinical practice.

The registry will be conducted at about 45 centers in China, where the CYPHER Select™+ Sirolimus-eluting Coronary Stent is commercially available. Data will be collected on 2,500 diabetic patients treated with the CYPHER Select™ + Sirolimus-eluting Coronary Stent only.

Primary outcome: MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months Secondary outcome: ARC (probable + definite) ST at 1-day, and 1 and 12 months

• Study Type: Observational
• Enrollment (Actual): 1603

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100037
    • Cardiovascular Institute & Fu Wai Hospital
  • Da Qing, China
    • General Hospital of Daqing Oilfield
  • Hang Zhou, China, 310016
    • Sir Run Run Shaw Hospital
  • Jinan, China, 250021
    • Shandong Provincial Hospital
  • Shanghai, China, 200072
    • Shanghai Tenth People's Hospital of Tongji University
  • Shen Yang, China, 110004
    • Shengjing Hospital of China Medical University
  • Tianjin, China
    • TEDA International Cardiovascular Hospital
  • Tianjin, China
    • The Affiliated Hospital of Medical College of Chinese Armed Police Forces
  • Wenzhou, China, 325000
    • The First Affiliated Hospital Of WenZhou Medical College
  • Xi'an, China, 710061
    • The First Hospital of Xian Jiao Tong University
  • Beijing
    • Beijing, Beijing, China
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital
    • Beijing, Beijing, China
      • Peking University Third Hospital
    • Beijing, Beijing, China
      • The General Hospital of the People's Liberation Army
    • Beijing, Beijing, China
      • Beijing Hospital
    • Beijing, Beijing, China
      • Beijing Chaoyang Hospital
    • Beijing, Beijing, China
      • Beijing Friendship Hospital
    • Beijing, Beijing, China, 100039
      • General Hospital of Armed Police Forces
    • Beijing, Beijing, China, 100730
      • Beijing Tongren Hospital Affiliated to Capital Medical University
    • Beijing, Beijing, China, 100029
      • Beijing Anzhen Hospital of the Capital University of Medical Science
    • Beijing, Beijing, China
      • Xuan Wu Hospital Capital Medical University
    • Beijng, Beijing, China, 100029
      • China-Japan Friendship Hospital
  • Fujian
    • Xiamen, Fujian, China
      • Zhongshan Hospital Xiamen University
  • Gansu
    • Lanzhou, Gansu, China
      • Lanzhou University First Hospita
  • Guangdong
    • Guangdong, Guangdong, China
      • Peking University, Shenzhen Hospital
    • Guangzhou, Guangdong, China
      • Guangdong General Hospital
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital,Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital affiliated to Southern Medical University
  • Hebei
    • ShiJiaZhuang, Hebei, China, 050082
      • Peace Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • The First Affiliated Hospital of Harbin Medical University
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Henan Provincial People's Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Nanjing First Hospital
  • Jilin
    • Changchun, Jilin, China
      • The Second Affiliated Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China
      • The First Hospital of China Medical University
    • Shenyang, Liaoning, China, 110015
      • The General Hospital of Shenyang Military Command
  • Shandong
    • Qingdao, Shandong, China
      • The Affiliated Hospital of Medical College Qingdao University
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital Fudan University
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
    • Shanghai, Shanghai, China
      • Shanghai Jiaotong University School of Medicine affiliated Renji Hospital
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • The First Hospital of Shanxi Medical University
    • Taiyuan, Shanxi, China, 030001
      • Shanxi Cardiovascular Hospital
    • Xian, Shanxi, China
      • Xijing Hospital
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin First Center Hospital
    • Tianjin, Tianjin, China
      • Tian Jin Chest Hospital
  • Xinjiang
    • Urumuqi, Xinjiang, China
      • People's Hospital of Xinjiang Uygur Autonomous Region
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Second Affiliated Hospital of Zhejiang University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The registry will be conducted at approximately 45 centers in China where the CYPHER SelectTM+ Sirolimus-eluting Coronary Stent is commercially available. Data will be collected on 2,500 diabetic patients treated only with the CYPHER Select™+ Sirolimus-eluting Coronary Stent during the index procedure. Enrolled diabetic patients are confirmed and diagnosed with Diabetes before or during the index procedure hospitalization, i.e., those receiving active treatment with an oral hypoglycemic agent or insulin, patients with diagnosis of diabetes who were on dietary therapy alone or patients with an abnormal blood glucose level after an overnight fast as defined by local standards.

Description

Inclusion Criteria:

• Patients between the ages of 18 and 80 (inclusive) receiving CYPHER SELECT™+ Sirolimus-eluting Coronary Stent according to standard clinical practice when financially feasible
• The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
• Patient has diagnosis of diabetes or is diagnosed with it before or during the index procedure hospitalization based on disease diagnosis criteria

Exclusion Criteria:

• Any contraindication to any of the following medications: aspirin, heparin, thienopyridines (clopidogrel/ticlopidine), stainless steel, contrast agents, or sirolimus
• An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment
• Cardiogenic shock
• Terminal illness with life expectancy <1 year
• ST-segment elevation myocardial infarction within 7 days prior to the index procedure
• Any patient who received coronary stent(s) within 1 year

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Diabetes patients with PCI; this is single group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
ARC (probable + definite) ST at 1-day, and 1 and 12 months	12 months

Collaborators and Investigators

• Sponsor: Johnson & Johnson Medical, China
• Investigators: Principal Investigator: Yang Yue Jin, MD, Phd, Cardiovascular Institute & Fu Wai Hospital; Principal Investigator: Lv Shu Zheng, MD, Beijing Anzhen Hospital of The Capital University of Medical Sciences; Principal Investigator: Chen Yun Dai, MD, Phd, Chinese PLA General Hospital; Principal Investigator: Wang Le feng, Beijing Chaoyang Hospital Affiliated to the Capital University of Medical Sciences; Principal Investigator: Gao Wei, MD, Phd, Peking University Third Hospital; Principal Investigator: Wang Wei Min, MD, PhD, Peking University People's Hospital; Principal Investigator: Huo Yong, MD, PhD, Peking University first hospital; Principal Investigator: Fang Quan, MD, PhD, Peking Union Medical College Hospital; Principal Investigator: He Qing, MD, PhD, Beijing Hospital; Principal Investigator: Liu Hui Liang, MD, General Hospital of Armed Police Forces; Principal Investigator: Li Hui, MD, General Hospital of Daqing Oilfield; Principal Investigator: Chen Ji Yan, MD, PhD, Guangdong Provincial People's Hospital; Principal Investigator: Du Zhi Min, MD, First Affiliated Hospital, Sun Yat-Sen University; Principal Investigator: Hou Yu Qing, MD, Southern Medical University, China; Principal Investigator: Li Wei Min, MD, First Affiliated Hospital of Harbin Medical University; Principal Investigator: Yu Bo, MD, The Second Affiliated Hospital of Harbin Medical University; Principal Investigator: Fu Guo Sheng, MD, Sir Run Run Shaw Hospital Affiliated with School of Medicine,Zhejiang University; Principal Investigator: Wang Jian An, MD, PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University; Principal Investigator: Zhu Jian Hua, MD, First Affiliated Hospital of Zhejiang University College of Medicine; Principal Investigator: Liu Bin, MD, The Second Affiliated Hospital of Jilin University; Principal Investigator: Cui Lian Qun, MD, PhD, Shandong Provincial Hospital; Principal Investigator: Zhang Zheng, MD, PhD, Lanzhou University First Hospital; Principal Investigator: Chen Shao Liang, MD, PhD, The First Affiliated Hospital with Nanjing Medical University; Principal Investigator: Xu Biao, MD, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Principal Investigator: Li Lang, MD, PhD, First Affiliated Hospital of Guangxi Medical University; Principal Investigator: Ge Jun Bo, MD, PhD, Fudan University; Principal Investigator: He Ben, MD,PhD, Shanghai Jiaotong University School of Medicine affiliated Renji Hospital; Principal Investigator: Shen Wei Feng, MD, PhD, Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital; Principal Investigator: Xu Ya Wei, MD, PhD, Shanghai Tenth People's Hospital of Tongji University; Principal Investigator: Han Ya Ling, MD, PhD, General Hospital of Shenyang Military Region; Principal Investigator: Pang Wen Yue, MD, PhD, Shengjing Hospital; Principal Investigator: Li Bao, MD,PhD, Shanxi Cardiovascular Hospital; Principal Investigator: Lv Ji Yuan, MD, The First Affiliated Hospital of Shanxi Medical University; Principal Investigator: Liu Yin, MD, PhD, Tian Jin Chest Hospital; Principal Investigator: Qi Xiang Qian, MD, TEDA International Cardiovascular Hospital; Principal Investigator: Jiang Tie Min, MD, The Affiliated Hospital of Medical College of Chinese Armed Police Forces; Principal Investigator: Lu Cheng Zhi, MD, Tianjin First Central Hospital; Principal Investigator: Huang Wei Jian, MD, PhD, First affiliated hospital of Wenzhou medical university; Principal Investigator: Sun Ying Xian, MD, First Hospital of China Medical University; Principal Investigator: Li Guo Qing, MD, People's Hospital of Xinjiang Uygur Autonomous Region; Principal Investigator: Yuan Zu Yi, MD, The First Hospital of Xian Jiao Tong University; Principal Investigator: Wang Hai Chang, MD, Xijing Hospital; Principal Investigator: Wang Yan, MD,PhD, Zhongshan Hospital Xiamen University; Principal Investigator: Gao Chuan Yu, MD, PhD, Henan Provincial People's Hospital; Principal Investigator: Wang Chun, MD, PhD, Peking University, Shen Zhen Hospital; Principal Investigator: Yong Wang, MD, PhD, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 24, 2009
• First Submitted That Met QC Criteria: July 10, 2009
• First Posted (Estimate): July 13, 2009

Study Record Updates

• Last Update Posted (Estimate): June 28, 2013
• Last Update Submitted That Met QC Criteria: June 27, 2013
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Diabetes Mellitus
• Other Study ID Numbers: CDS-200801