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Care China-Diabetes

2013年6月27日 更新者：Johnson & Johnson Medical, China

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.

研究概览

地位

终止

条件

详细说明

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

研究类型

观察性的

注册 (实际的)

1603

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Diabetes patients with PCI
this is single group

研究衡量的是什么？

主要结果指标

结果测量
大体时间
MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months
大体时间：12 months
12 months

次要结果测量

结果测量
大体时间
ARC (probable + definite) ST at 1-day, and 1 and 12 months
大体时间：12 months
12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Johnson & Johnson Medical, China

调查人员

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

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年8月1日

初级完成 (实际的)

2011年11月1日

研究完成 (实际的)

2012年12月1日

研究注册日期

首次提交

2009年6月24日

首先提交符合 QC 标准的

2009年7月10日

首次发布 (估计)

2009年7月13日

研究记录更新

最后更新发布 (估计)

2013年6月28日

上次提交的符合 QC 标准的更新

2013年6月27日

最后验证

2011年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CDS-200801

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