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Care China-Diabetes

27 juni 2013 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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

Studietyp

Observationell

Inskrivning (Faktisk)

1603

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Diabetes patients with PCI
this is single group

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months
Tidsram: 12 months
12 months

Sekundära resultatmått

Resultatmått
Tidsram
ARC (probable + definite) ST at 1-day, and 1 and 12 months
Tidsram: 12 months
12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Johnson & Johnson Medical, China

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2009

Primärt slutförande (Faktisk)

1 november 2011

Avslutad studie (Faktisk)

1 december 2012

Studieregistreringsdatum

Först inskickad

24 juni 2009

Först inskickad som uppfyllde QC-kriterierna

10 juli 2009

Första postat (Uppskatta)

13 juli 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

28 juni 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 juni 2013

Senast verifierad

1 juli 2011

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CDS-200801

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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