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Care China-Diabetes

27. juni 2013 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1603

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Diabetes patients with PCI
this is single group

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months
Tidsramme: 12 months
12 months

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Johnson & Johnson Medical, China

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2009

Primær færdiggørelse (Faktiske)

1. november 2011

Studieafslutning (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

24. juni 2009

Først indsendt, der opfyldte QC-kriterier

10. juli 2009

Først opslået (Skøn)

13. juli 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. juni 2013

Sidst verificeret

1. juli 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDS-200801

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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