Care China-Diabetes
27 juin 2013 mis à jour par: 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.
Aperçu de l'étude
Statut
Résilié
Les conditions
Description détaillée
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
Type d'étude
Observationnel
Inscription (Réel)
1603
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Beijing, Chine, 100037
- Cardiovascular Institute & Fu Wai Hospital
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Da Qing, Chine
- General Hospital of Daqing Oilfield
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Hang Zhou, Chine, 310016
- Sir Run Run Shaw Hospital
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Jinan, Chine, 250021
- Shandong Provincial Hospital
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Shanghai, Chine, 200072
- Shanghai Tenth People's Hospital of Tongji University
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Shen Yang, Chine, 110004
- Shengjing Hospital of China Medical University
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Tianjin, Chine
- TEDA International Cardiovascular Hospital
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Tianjin, Chine
- The Affiliated Hospital of Medical College of Chinese Armed Police Forces
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Wenzhou, Chine, 325000
- The First Affiliated Hospital of Wenzhou Medical College
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Xi'an, Chine, 710061
- The First Hospital of Xian Jiao Tong University
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Beijing
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Beijing, Beijing, Chine
- Peking Union Medical College Hospital
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Beijing, Beijing, Chine, 100044
- Peking University People's Hospital
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Beijing, Beijing, Chine
- Peking University Third Hospital
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Beijing, Beijing, Chine
- The General Hospital of the People's Liberation Army
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Beijing, Beijing, Chine
- Beijing Hospital
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Beijing, Beijing, Chine
- Beijing ChaoYang Hospital
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Beijing, Beijing, Chine
- Beijing Friendship Hospital
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Beijing, Beijing, Chine, 100039
- General Hospital of Armed Police Forces
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Beijing, Beijing, Chine, 100730
- Beijing Tongren Hospital affiliated to Capital Medical University
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Beijing, Beijing, Chine, 100029
- Beijing Anzhen Hospital of the Capital University of Medical Science
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Beijing, Beijing, Chine
- Xuan Wu Hospital Capital Medical University
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Beijng, Beijing, Chine, 100029
- China-Japan Friendship Hospital
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Fujian
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Xiamen, Fujian, Chine
- Zhongshan Hospital Xiamen University
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Gansu
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Lanzhou, Gansu, Chine
- Lanzhou University First Hospita
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Guangdong
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Guangdong, Guangdong, Chine
- Peking University, Shenzhen Hospital
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Guangzhou, Guangdong, Chine
- Guangdong General Hospital
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Guangzhou, Guangdong, Chine
- The first affiliated hospital,Sun yat-sen university
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Guangzhou, Guangdong, Chine, 510515
- Nanfang Hospital affiliated to Southern Medical University
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Hebei
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ShiJiaZhuang, Hebei, Chine, 050082
- Peace Hospital
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Heilongjiang
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Harbin, Heilongjiang, Chine
- The First Affiliated Hospital Of Harbin Medical University
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Henan
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Zhengzhou, Henan, Chine, 450000
- Henan Provincial People's Hospital
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Jiangsu
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Nanjing, Jiangsu, Chine
- Nanjing First Hospital
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Jilin
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Changchun, Jilin, Chine
- The Second Affiliated Hospital of Jilin University
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Liaoning
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Shenyang, Liaoning, Chine
- The First Hospital of China Medical University
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Shenyang, Liaoning, Chine, 110015
- The General Hospital of Shenyang Military Command
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Shandong
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Qingdao, Shandong, Chine
- The Affiliated Hospital of Medical College Qingdao University
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Shanghai
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Shanghai, Shanghai, Chine, 200032
- Zhongshan Hospital Fudan University
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Shanghai, Shanghai, Chine, 200025
- Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
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Shanghai, Shanghai, Chine
- Shanghai Jiaotong University School of Medicine affiliated Renji Hospital
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Shanxi
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Taiyuan, Shanxi, Chine, 030001
- The First Hospital of Shanxi Medical University
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Taiyuan, Shanxi, Chine, 030001
- Shanxi Cardiovascular Hospital
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Xian, Shanxi, Chine
- Xijing Hospital
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Tianjin
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Tianjin, Tianjin, Chine
- Tianjin First Center Hospital
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Tianjin, Tianjin, Chine
- Tian Jin Chest Hospital
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Xinjiang
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Urumuqi, Xinjiang, Chine
- People's Hospital of Xinjiang Uygur Autonomous Region
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Zhejiang
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Hangzhou, Zhejiang, Chine, 310009
- Second Affiliated Hospital of Zhejiang University College of Medicine
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 80 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
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.
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Diabetes patients with PCI
this is single group
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months
Délai: 12 months
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12 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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ARC (probable + definite) ST at 1-day, and 1 and 12 months
Délai: 12 months
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12 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Yang Yue Jin, MD, Phd, Cardiovascular Institute & Fu Wai Hospital
- Chercheur principal: Lv Shu Zheng, MD, Beijing Anzhen Hospital of the Capital University of Medical Sciences
- Chercheur principal: Chen Yun Dai, MD, Phd, Chinese PLA General Hospital
- Chercheur principal: Wang Le feng, Beijing Chaoyang Hospital Affiliated to the Capital University of Medical Sciences
- Chercheur principal: Gao Wei, MD, Phd, Peking University Third Hospital
- Chercheur principal: Wang Wei Min, MD, PhD, Peking University People's Hospital
- Chercheur principal: Huo Yong, MD, PhD, Peking University First Hospital
- Chercheur principal: Fang Quan, MD, PhD, Peking Union Medical College Hospital
- Chercheur principal: He Qing, MD, PhD, Beijing Hospital
- Chercheur principal: Liu Hui Liang, MD, General Hospital of Armed Police Forces
- Chercheur principal: Li Hui, MD, General Hospital of Daqing Oilfield
- Chercheur principal: Chen Ji Yan, MD, PhD, Guangdong Provincial People's Hospital
- Chercheur principal: Du Zhi Min, MD, First Affiliated Hospital, Sun Yat-Sen University
- Chercheur principal: Hou Yu Qing, MD, Southern Medical University, China
- Chercheur principal: Li Wei Min, MD, First Affiliated Hospital of Harbin Medical University
- Chercheur principal: Yu Bo, MD, The Second Affiliated Hospital of Harbin Medical University
- Chercheur principal: Fu Guo Sheng, MD, Sir Run Run Shaw Hospital Affiliated with School of Medicine,Zhejiang University
- Chercheur principal: Wang Jian An, MD, PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University
- Chercheur principal: Zhu Jian Hua, MD, First Affiliated Hospital of Zhejiang University College of Medicine
- Chercheur principal: Liu Bin, MD, The Second Affiliated Hospital of Jilin University
- Chercheur principal: Cui Lian Qun, MD, PhD, Shandong Provincial Hospital
- Chercheur principal: Zhang Zheng, MD, PhD, Lanzhou University First Hospital
- Chercheur principal: Chen Shao Liang, MD, PhD, The First Affiliated Hospital with Nanjing Medical University
- Chercheur principal: Xu Biao, MD, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Chercheur principal: Li Lang, MD, PhD, First Affiliated Hospital of Guangxi Medical University
- Chercheur principal: Ge Jun Bo, MD, PhD, Fudan University
- Chercheur principal: He Ben, MD,PhD, Shanghai Jiaotong University School of Medicine affiliated Renji Hospital
- Chercheur principal: Shen Wei Feng, MD, PhD, Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
- Chercheur principal: Xu Ya Wei, MD, PhD, Shanghai Tenth People's Hospital of Tongji University
- Chercheur principal: Han Ya Ling, MD, PhD, General Hospital of Shenyang Military Region
- Chercheur principal: Pang Wen Yue, MD, PhD, Shengjing Hospital
- Chercheur principal: Li Bao, MD,PhD, Shanxi Cardiovascular Hospital
- Chercheur principal: Lv Ji Yuan, MD, The First Affiliated Hospital of Shanxi Medical University
- Chercheur principal: Liu Yin, MD, PhD, Tian Jin Chest Hospital
- Chercheur principal: Qi Xiang Qian, MD, TEDA International Cardiovascular Hospital
- Chercheur principal: Jiang Tie Min, MD, The Affiliated Hospital of Medical College of Chinese Armed Police Forces
- Chercheur principal: Lu Cheng Zhi, MD, Tianjin First Central Hospital
- Chercheur principal: Huang Wei Jian, MD, PhD, First Affiliated Hospital of Wenzhou Medical University
- Chercheur principal: Sun Ying Xian, MD, First Hospital of China Medical University
- Chercheur principal: Li Guo Qing, MD, People's Hospital of Xinjiang Uygur Autonomous Region
- Chercheur principal: Yuan Zu Yi, MD, The First Hospital of Xian Jiao Tong University
- Chercheur principal: Wang Hai Chang, MD, Xijing Hospital
- Chercheur principal: Wang Yan, MD,PhD, Zhongshan Hospital Xiamen University
- Chercheur principal: Gao Chuan Yu, MD, PhD, Henan Provincial People's Hospital
- Chercheur principal: Wang Chun, MD, PhD, Peking University, Shen Zhen Hospital
- Chercheur principal: Yong Wang, MD, PhD, China-Japan Friendship Hospital
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 août 2009
Achèvement primaire (Réel)
1 novembre 2011
Achèvement de l'étude (Réel)
1 décembre 2012
Dates d'inscription aux études
Première soumission
24 juin 2009
Première soumission répondant aux critères de contrôle qualité
10 juillet 2009
Première publication (Estimation)
13 juillet 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
28 juin 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
27 juin 2013
Dernière vérification
1 juillet 2011
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CDS-200801
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .