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Care China-Diabetes

27 de junho de 2013 atualizado por: 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.

Visão geral do estudo

Status

Rescindido

Condições

Descrição detalhada

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

Tipo de estudo

Observacional

Inscrição (Real)

1603

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • 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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Diabetes patients with PCI
this is single group

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months
Prazo: 12 months
12 months

Medidas de resultados secundários

Medida de resultado
Prazo
ARC (probable + definite) ST at 1-day, and 1 and 12 months
Prazo: 12 months
12 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Johnson & Johnson Medical, China

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de agosto de 2009

Conclusão Primária (Real)

1 de novembro de 2011

Conclusão do estudo (Real)

1 de dezembro de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

24 de junho de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de julho de 2009

Primeira postagem (Estimativa)

13 de julho de 2009

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

28 de junho de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de junho de 2013

Última verificação

1 de julho de 2011

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CDS-200801

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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