Care China-Diabetes
27 giugno 2013 aggiornato da: 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.
Panoramica dello studio
Stato
Terminato
Condizioni
Descrizione dettagliata
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 di studio
Osservativo
Iscrizione (Effettivo)
1603
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Beijing, Cina, 100037
- Cardiovascular Institute & Fu Wai Hospital
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Da Qing, Cina
- General Hospital of Daqing Oilfield
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Hang Zhou, Cina, 310016
- Sir Run Run Shaw Hospital
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Jinan, Cina, 250021
- Shandong Provincial Hospital
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Shanghai, Cina, 200072
- Shanghai Tenth People's Hospital of Tongji University
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Shen Yang, Cina, 110004
- Shengjing Hospital of China Medical University
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Tianjin, Cina
- TEDA International Cardiovascular Hospital
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Tianjin, Cina
- The Affiliated Hospital of Medical College of Chinese Armed Police Forces
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Wenzhou, Cina, 325000
- The First Affiliated Hospital of Wenzhou Medical College
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Xi'an, Cina, 710061
- The First Hospital of Xian Jiao Tong University
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Beijing
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Beijing, Beijing, Cina
- Peking Union Medical College Hospital
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Beijing, Beijing, Cina, 100044
- Peking University People's Hospital
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Beijing, Beijing, Cina
- Peking University Third Hospital
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Beijing, Beijing, Cina
- The General Hospital of the People's Liberation Army
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Beijing, Beijing, Cina
- Beijing Hospital
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Beijing, Beijing, Cina
- Beijing Chaoyang Hospital
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Beijing, Beijing, Cina
- Beijing Friendship Hospital
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Beijing, Beijing, Cina, 100039
- General Hospital of Armed Police Forces
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Beijing, Beijing, Cina, 100730
- Beijing Tongren Hospital Affiliated to Capital Medical University
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Beijing, Beijing, Cina, 100029
- Beijing Anzhen Hospital of the Capital University of Medical Science
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Beijing, Beijing, Cina
- Xuan Wu Hospital Capital Medical University
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Beijng, Beijing, Cina, 100029
- China-Japan Friendship Hospital
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Fujian
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Xiamen, Fujian, Cina
- Zhongshan Hospital Xiamen University
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Gansu
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Lanzhou, Gansu, Cina
- Lanzhou University First Hospita
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Guangdong
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Guangdong, Guangdong, Cina
- Peking University, Shenzhen Hospital
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Guangzhou, Guangdong, Cina
- Guangdong General Hospital
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Guangzhou, Guangdong, Cina
- The First Affiliated Hospital,Sun Yat-sen University
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Guangzhou, Guangdong, Cina, 510515
- Nanfang Hospital affiliated to Southern Medical University
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Hebei
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ShiJiaZhuang, Hebei, Cina, 050082
- Peace Hospital
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Heilongjiang
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Harbin, Heilongjiang, Cina
- The First Affiliated Hospital of Harbin Medical University
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Henan
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Zhengzhou, Henan, Cina, 450000
- Henan Provincial People's Hospital
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Jiangsu
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Nanjing, Jiangsu, Cina
- Nanjing First Hospital
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Jilin
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Changchun, Jilin, Cina
- The Second Affiliated Hospital of Jilin University
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Liaoning
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Shenyang, Liaoning, Cina
- The First Hospital of China Medical University
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Shenyang, Liaoning, Cina, 110015
- The General Hospital of Shenyang Military Command
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Shandong
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Qingdao, Shandong, Cina
- The Affiliated Hospital of Medical College Qingdao University
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Shanghai
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Shanghai, Shanghai, Cina, 200032
- Zhongshan Hospital Fudan University
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Shanghai, Shanghai, Cina, 200025
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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Shanghai, Shanghai, Cina
- Shanghai Jiaotong University School of Medicine affiliated Renji Hospital
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Shanxi
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Taiyuan, Shanxi, Cina, 030001
- The First Hospital of Shanxi Medical University
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Taiyuan, Shanxi, Cina, 030001
- Shanxi Cardiovascular Hospital
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Xian, Shanxi, Cina
- Xijing Hospital
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Tianjin
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Tianjin, Tianjin, Cina
- Tianjin First Center Hospital
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Tianjin, Tianjin, Cina
- Tian Jin Chest Hospital
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Xinjiang
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Urumuqi, Xinjiang, Cina
- People's Hospital of Xinjiang Uygur Autonomous Region
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Zhejiang
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Hangzhou, Zhejiang, Cina, 310009
- Second Affiliated Hospital of Zhejiang University College of Medicine
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 80 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
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.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Diabetes patients with PCI
this is single group
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months
Lasso di tempo: 12 months
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12 months
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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ARC (probable + definite) ST at 1-day, and 1 and 12 months
Lasso di tempo: 12 months
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12 months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Yang Yue Jin, MD, Phd, Cardiovascular Institute & Fu Wai Hospital
- Investigatore principale: Lv Shu Zheng, MD, Beijing Anzhen Hospital of the Capital University of Medical Sciences
- Investigatore principale: Chen Yun Dai, MD, Phd, Chinese PLA General Hospital
- Investigatore principale: Wang Le feng, Beijing Chaoyang Hospital Affiliated to the Capital University of Medical Sciences
- Investigatore principale: Gao Wei, MD, Phd, Peking University Third Hospital
- Investigatore principale: Wang Wei Min, MD, PhD, Peking University People's Hospital
- Investigatore principale: Huo Yong, MD, PhD, Peking University First Hospital
- Investigatore principale: Fang Quan, MD, PhD, Peking Union Medical College Hospital
- Investigatore principale: He Qing, MD, PhD, Beijing Hospital
- Investigatore principale: Liu Hui Liang, MD, General Hospital of Armed Police Forces
- Investigatore principale: Li Hui, MD, General Hospital of Daqing Oilfield
- Investigatore principale: Chen Ji Yan, MD, PhD, Guangdong Provincial People's Hospital
- Investigatore principale: Du Zhi Min, MD, First Affiliated Hospital, Sun Yat-Sen University
- Investigatore principale: Hou Yu Qing, MD, Southern Medical University, China
- Investigatore principale: Li Wei Min, MD, First Affiliated Hospital of Harbin Medical University
- Investigatore principale: Yu Bo, MD, The Second Affiliated Hospital of Harbin Medical University
- Investigatore principale: Fu Guo Sheng, MD, Sir Run Run Shaw Hospital Affiliated with School of Medicine,Zhejiang University
- Investigatore principale: Wang Jian An, MD, PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University
- Investigatore principale: Zhu Jian Hua, MD, First Affiliated Hospital of Zhejiang University College of Medicine
- Investigatore principale: Liu Bin, MD, The Second Affiliated Hospital of Jilin University
- Investigatore principale: Cui Lian Qun, MD, PhD, Shandong Provincial Hospital
- Investigatore principale: Zhang Zheng, MD, PhD, Lanzhou University First Hospital
- Investigatore principale: Chen Shao Liang, MD, PhD, The First Affiliated Hospital with Nanjing Medical University
- Investigatore principale: Xu Biao, MD, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigatore principale: Li Lang, MD, PhD, First Affiliated Hospital of Guangxi Medical University
- Investigatore principale: Ge Jun Bo, MD, PhD, Fudan University
- Investigatore principale: He Ben, MD,PhD, Shanghai Jiaotong University School of Medicine affiliated Renji Hospital
- Investigatore principale: Shen Wei Feng, MD, PhD, Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
- Investigatore principale: Xu Ya Wei, MD, PhD, Shanghai Tenth People's Hospital of Tongji University
- Investigatore principale: Han Ya Ling, MD, PhD, General Hospital of Shenyang Military Region
- Investigatore principale: Pang Wen Yue, MD, PhD, Shengjing Hospital
- Investigatore principale: Li Bao, MD,PhD, Shanxi Cardiovascular Hospital
- Investigatore principale: Lv Ji Yuan, MD, The First Affiliated Hospital of Shanxi Medical University
- Investigatore principale: Liu Yin, MD, PhD, Tian Jin Chest Hospital
- Investigatore principale: Qi Xiang Qian, MD, TEDA International Cardiovascular Hospital
- Investigatore principale: Jiang Tie Min, MD, The Affiliated Hospital of Medical College of Chinese Armed Police Forces
- Investigatore principale: Lu Cheng Zhi, MD, TianJin First Central Hospital
- Investigatore principale: Huang Wei Jian, MD, PhD, First Affiliated Hospital of Wenzhou Medical University
- Investigatore principale: Sun Ying Xian, MD, First Hospital of China Medical University
- Investigatore principale: Li Guo Qing, MD, People's Hospital of Xinjiang Uygur Autonomous Region
- Investigatore principale: Yuan Zu Yi, MD, The First Hospital of Xian Jiao Tong University
- Investigatore principale: Wang Hai Chang, MD, Xijing Hospital
- Investigatore principale: Wang Yan, MD,PhD, Zhongshan Hospital Xiamen University
- Investigatore principale: Gao Chuan Yu, MD, PhD, Henan Provincial People's Hospital
- Investigatore principale: Wang Chun, MD, PhD, Peking University, Shen Zhen Hospital
- Investigatore principale: Yong Wang, MD, PhD, China-Japan Friendship Hospital
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2009
Completamento primario (Effettivo)
1 novembre 2011
Completamento dello studio (Effettivo)
1 dicembre 2012
Date di iscrizione allo studio
Primo inviato
24 giugno 2009
Primo inviato che soddisfa i criteri di controllo qualità
10 luglio 2009
Primo Inserito (Stima)
13 luglio 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
28 giugno 2013
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 giugno 2013
Ultimo verificato
1 luglio 2011
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CDS-200801
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .