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Care China-Diabetes

2013년 6월 27일 업데이트: 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.

연구 개요

상태

종료됨

정황

상세 설명

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

연구 유형

관찰

등록 (실제)

1603

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
Diabetes patients with PCI
this is single group

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months
기간: 12 months
12 months

2차 결과 측정

결과 측정
기간
ARC (probable + definite) ST at 1-day, and 1 and 12 months
기간: 12 months
12 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Johnson & Johnson Medical, China

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 8월 1일

기본 완료 (실제)

2011년 11월 1일

연구 완료 (실제)

2012년 12월 1일

연구 등록 날짜

최초 제출

2009년 6월 24일

QC 기준을 충족하는 최초 제출

2009년 7월 10일

처음 게시됨 (추정)

2009년 7월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 6월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 6월 27일

마지막으로 확인됨

2011년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CDS-200801

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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