Care China-Diabetes
27 de junio de 2013 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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
Tipo de estudio
De observación
Inscripción (Actual)
1603
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Beijing, Porcelana, 100037
- Cardiovascular Institute & Fu Wai Hospital
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Da Qing, Porcelana
- General Hospital of Daqing Oilfield
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Hang Zhou, Porcelana, 310016
- Sir Run Run Shaw Hospital
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Jinan, Porcelana, 250021
- Shandong Provincial Hospital
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Shanghai, Porcelana, 200072
- Shanghai Tenth People's Hospital of Tongji University
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Shen Yang, Porcelana, 110004
- Shengjing Hospital of China Medical University
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Tianjin, Porcelana
- Teda International Cardiovascular Hospital
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Tianjin, Porcelana
- The Affiliated Hospital of Medical College of Chinese Armed Police Forces
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Wenzhou, Porcelana, 325000
- The First Affiliated Hospital of Wenzhou Medical College
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Xi'an, Porcelana, 710061
- The First Hospital of Xian Jiao Tong University
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Beijing
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Beijing, Beijing, Porcelana
- Peking Union Medical College Hospital
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Beijing, Beijing, Porcelana, 100044
- Peking University People's Hospital
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Beijing, Beijing, Porcelana
- Peking University Third Hospital
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Beijing, Beijing, Porcelana
- The General Hospital of the People's Liberation Army
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Beijing, Beijing, Porcelana
- Beijing Hospital
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Beijing, Beijing, Porcelana
- Beijing Chaoyang Hospital
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Beijing, Beijing, Porcelana
- Beijing Friendship Hospital
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Beijing, Beijing, Porcelana, 100039
- General Hospital of Armed Police Forces
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Beijing, Beijing, Porcelana, 100730
- Beijing Tongren Hospital affiliated to Capital Medical University
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Beijing, Beijing, Porcelana, 100029
- Beijing Anzhen Hospital of the Capital University of Medical Science
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Beijing, Beijing, Porcelana
- Xuan Wu Hospital Capital Medical University
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Beijng, Beijing, Porcelana, 100029
- China-Japan Friendship Hospital
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Fujian
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Xiamen, Fujian, Porcelana
- Zhongshan Hospital Xiamen University
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Gansu
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Lanzhou, Gansu, Porcelana
- Lanzhou University First Hospita
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Guangdong
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Guangdong, Guangdong, Porcelana
- Peking University, Shenzhen Hospital
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Guangzhou, Guangdong, Porcelana
- Guangdong General Hospital
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Guangzhou, Guangdong, Porcelana
- The First Affiliated Hospital,Sun Yat-sen University
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Guangzhou, Guangdong, Porcelana, 510515
- Nanfang Hospital affiliated to Southern Medical University
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Hebei
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ShiJiaZhuang, Hebei, Porcelana, 050082
- Peace Hospital
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Heilongjiang
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Harbin, Heilongjiang, Porcelana
- The First Affiliated Hospital of Harbin Medical University
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Henan
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Zhengzhou, Henan, Porcelana, 450000
- Henan Provincial People's Hospital
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Jiangsu
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Nanjing, Jiangsu, Porcelana
- Nanjing First Hospital
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Jilin
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Changchun, Jilin, Porcelana
- The Second Affiliated Hospital of Jilin University
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Liaoning
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Shenyang, Liaoning, Porcelana
- The First Hospital of China Medical University
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Shenyang, Liaoning, Porcelana, 110015
- The General Hospital of Shenyang Military Command
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Shandong
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Qingdao, Shandong, Porcelana
- The Affiliated Hospital of Medical College Qingdao University
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Shanghai
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Shanghai, Shanghai, Porcelana, 200032
- Zhongshan Hospital Fudan University
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Shanghai, Shanghai, Porcelana, 200025
- Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
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Shanghai, Shanghai, Porcelana
- Shanghai Jiaotong University School of Medicine affiliated Renji Hospital
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Shanxi
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Taiyuan, Shanxi, Porcelana, 030001
- The First Hospital of Shanxi Medical University
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Taiyuan, Shanxi, Porcelana, 030001
- Shanxi Cardiovascular Hospital
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Xian, Shanxi, Porcelana
- Xijing Hospital
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Tianjin
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Tianjin, Tianjin, Porcelana
- Tianjin First Center Hospital
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Tianjin, Tianjin, Porcelana
- Tian Jin Chest Hospital
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Xinjiang
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Urumuqi, Xinjiang, Porcelana
- People's Hospital of Xinjiang Uygur Autonomous Region
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310009
- Second Affiliated Hospital of Zhejiang University College of Medicine
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
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.
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Diabetes patients with PCI
this is single group
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months
Periodo de tiempo: 12 months
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12 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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ARC (probable + definite) ST at 1-day, and 1 and 12 months
Periodo de tiempo: 12 months
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12 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Yang Yue Jin, MD, Phd, Cardiovascular Institute & Fu Wai Hospital
- Investigador principal: Lv Shu Zheng, MD, Beijing Anzhen Hospital of the Capital University of Medical Sciences
- Investigador principal: Chen Yun Dai, MD, Phd, Chinese PLA General Hospital
- Investigador principal: Wang Le feng, Beijing Chaoyang Hospital Affiliated to the Capital University of Medical Sciences
- Investigador principal: Gao Wei, MD, Phd, Peking University Third Hospital
- Investigador principal: Wang Wei Min, MD, PhD, Peking University People's Hospital
- Investigador principal: Huo Yong, MD, PhD, Peking University First Hospital
- Investigador principal: Fang Quan, MD, PhD, Peking Union Medical College Hospital
- Investigador principal: He Qing, MD, PhD, Beijing Hospital
- Investigador principal: Liu Hui Liang, MD, General Hospital of Armed Police Forces
- Investigador principal: Li Hui, MD, General Hospital of Daqing Oilfield
- Investigador principal: Chen Ji Yan, MD, PhD, Guangdong Provincial People's Hospital
- Investigador principal: Du Zhi Min, MD, First Affiliated Hospital, Sun Yat-Sen University
- Investigador principal: Hou Yu Qing, MD, Southern Medical University, China
- Investigador principal: Li Wei Min, MD, First Affiliated Hospital of Harbin Medical University
- Investigador principal: Yu Bo, MD, The Second Affiliated Hospital of Harbin Medical University
- Investigador principal: Fu Guo Sheng, MD, Sir Run Run Shaw Hospital Affiliated with School of Medicine,Zhejiang University
- Investigador principal: Wang Jian An, MD, PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University
- Investigador principal: Zhu Jian Hua, MD, First Affiliated Hospital of Zhejiang University College of Medicine
- Investigador principal: Liu Bin, MD, The Second Affiliated Hospital of Jilin University
- Investigador principal: Cui Lian Qun, MD, PhD, Shandong Provincial Hospital
- Investigador principal: Zhang Zheng, MD, PhD, Lanzhou University First Hospital
- Investigador principal: Chen Shao Liang, MD, PhD, The First Affiliated Hospital with Nanjing Medical University
- Investigador principal: Xu Biao, MD, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigador principal: Li Lang, MD, PhD, First Affiliated Hospital of Guangxi Medical University
- Investigador principal: Ge Jun Bo, MD, PhD, Fudan University
- Investigador principal: He Ben, MD,PhD, Shanghai Jiaotong University School of Medicine affiliated Renji Hospital
- Investigador principal: Shen Wei Feng, MD, PhD, Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
- Investigador principal: Xu Ya Wei, MD, PhD, Shanghai Tenth People's Hospital of Tongji University
- Investigador principal: Han Ya Ling, MD, PhD, General Hospital of Shenyang Military Region
- Investigador principal: Pang Wen Yue, MD, PhD, Shengjing Hospital
- Investigador principal: Li Bao, MD,PhD, Shanxi Cardiovascular Hospital
- Investigador principal: Lv Ji Yuan, MD, The First Affiliated Hospital of Shanxi Medical University
- Investigador principal: Liu Yin, MD, PhD, Tian Jin Chest Hospital
- Investigador principal: Qi Xiang Qian, MD, Teda International Cardiovascular Hospital
- Investigador principal: Jiang Tie Min, MD, The Affiliated Hospital of Medical College of Chinese Armed Police Forces
- Investigador principal: Lu Cheng Zhi, MD, Tianjin First Central Hospital
- Investigador principal: Huang Wei Jian, MD, PhD, First Affiliated Hospital of Wenzhou Medical University
- Investigador principal: Sun Ying Xian, MD, First Hospital of China Medical University
- Investigador principal: Li Guo Qing, MD, People's Hospital of Xinjiang Uygur Autonomous Region
- Investigador principal: Yuan Zu Yi, MD, The First Hospital of Xian Jiao Tong University
- Investigador principal: Wang Hai Chang, MD, Xijing Hospital
- Investigador principal: Wang Yan, MD,PhD, Zhongshan Hospital Xiamen University
- Investigador principal: Gao Chuan Yu, MD, PhD, Henan Provincial People's Hospital
- Investigador principal: Wang Chun, MD, PhD, Peking University, Shen Zhen Hospital
- Investigador principal: Yong Wang, MD, PhD, China-Japan Friendship Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de agosto de 2009
Finalización primaria (Actual)
1 de noviembre de 2011
Finalización del estudio (Actual)
1 de diciembre de 2012
Fechas de registro del estudio
Enviado por primera vez
24 de junio de 2009
Primero enviado que cumplió con los criterios de control de calidad
10 de julio de 2009
Publicado por primera vez (Estimar)
13 de julio de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
28 de junio de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
27 de junio de 2013
Última verificación
1 de julio de 2011
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CDS-200801
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .