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Care China-Diabetes

27. juni 2013 oppdatert 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.

Studieoversikt

Status

Avsluttet

Forhold

Detaljert 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

Studietype

Observasjonsmessig

Registrering (Faktiske)

1603

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Diabetes patients with PCI
this is single group

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Johnson & Johnson Medical, China

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2009

Primær fullføring (Faktiske)

1. november 2011

Studiet fullført (Faktiske)

1. desember 2012

Datoer for studieregistrering

Først innsendt

24. juni 2009

Først innsendt som oppfylte QC-kriteriene

10. juli 2009

Først lagt ut (Anslag)

13. juli 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

28. juni 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. juni 2013

Sist bekreftet

1. juli 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDS-200801

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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