Care China-Diabetes
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Purpose
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.
| Condition |
|---|
|
Cardiovascular Disease Diabetes |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | 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 |
- MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- ARC (probable + definite) ST at 1-day, and 1 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Biospecimen Retention: None Retained
Diabetes patient
| Enrollment: | 1610 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | August 2013 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Diabetes patients with PCI
this is single group
|
Detailed Description:
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
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
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
Contacts and Locations
Show 46 Study Locations| Principal Investigator: | Yang Yue Jin, MD, Phd | Cardiovascular Institute & Fu Wai Hospital |
| Principal Investigator: | Lv Shu Zheng, MD | Beijing Anzhen Hospital of the Capital University of Medical Sciences |
| Principal Investigator: | Chen Yun Dai, MD, Phd | The General Hospital of the People's Liberation Army |
| Principal Investigator: | Wang Le feng | Beijing Chaoyang Hospital Affiliated to the Capital University of Medical Sciences |
| Principal Investigator: | Gao Wei, MD, Phd | Peking University Third Hospital |
| Principal Investigator: | Wang Wei Min, MD, PhD | Peking University People's Hospital |
| Principal Investigator: | Huo Yong, MD, PhD | Peking University First Hospital |
| Principal Investigator: | Fang Quan, MD, PhD | Peking Union Medical College Hospital |
| Principal Investigator: | He Qing, MD, PhD | Beijing Hospital |
| Principal Investigator: | Liu Hui Liang, MD | General Hospital of Armed Police Forces |
| Principal Investigator: | Li Hui, MD | General Hospital of Daqing Oilfield |
| Principal Investigator: | Chen Ji Yan, MD, PhD | Guangdong General Hospital |
| Principal Investigator: | Du Zhi Min, MD | First Affiliated Hospital, Sun Yat-Sen University |
| Principal Investigator: | Hou Yu Qing, MD | NanFang Hospital Affiliated to Southern Medical University |
| Principal Investigator: | Li Wei Min, MD | First Affiliated Hospital of Harbin Medical University |
| Principal Investigator: | Yu Bo, MD | The Second Affiliated Hospital of Harbin Medical University |
| Principal Investigator: | Fu Guo Sheng, MD | Sir Run Run Shaw Hospital Affiliated with School of Medicine,Zhejiang University |
| Principal Investigator: | Wang Jian An, MD, PhD | Second Affiliated Hospital of Zhejiang University college of Medicine |
| Principal Investigator: | Zhu Jian Hua, MD | First Affiliated Hospital of Zhejiang University College of Medicine |
| Principal Investigator: | Liu Bin, MD | The Second Affiliated Hospital of Jilin University |
| Principal Investigator: | Cui Lian Qun, MD, PhD | Shandong Provincial Hospital |
| Principal Investigator: | Zhang Zheng, MD, PhD | Lanzhou University First Hospital |
| Principal Investigator: | Chen Shao Liang, MD, PhD | Nanjing First Hospital |
| Principal Investigator: | Xu Biao, MD | Nanjing Drum Tower Hospital |
| Principal Investigator: | Li Lang, MD, PhD | Guangxi Medical University |
| Principal Investigator: | Ge Jun Bo, MD, PhD | Fudan University |
| Principal Investigator: | He Ben, MD,PhD | Shanghai Jiaotong University School of Medicine affiliated Renji Hospital |
| Principal Investigator: | Shen Wei Feng, MD, PhD | Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital |
| Principal Investigator: | Xu Ya Wei, MD, PhD | Shanghai Tenth People's Hospital of Tongji University |
| Principal Investigator: | Han Ya Ling, MD, PhD | General Hospital of Shenyang Military Region |
| Principal Investigator: | Pang Wen Yue, MD, PhD | Shengjing Hospital |
| Principal Investigator: | Li Bao, MD,PhD | Shanxi Cardiovascular Hospital |
| Principal Investigator: | Lv Ji Yuan, MD | The First Hospital of Shanxi Medical University |
| Principal Investigator: | Liu Yin, MD, PhD | Tian Jin Chest Hospital |
| Principal Investigator: | Qi Xiang Qian, MD | Teda International Cardiovascular Hospital |
| Principal Investigator: | Jiang Tie Min, MD | The Affiliated Hospital of Medical College of Chinese Armed Police Forces |
| Principal Investigator: | Lu Cheng Zhi, MD | Tianjin First Center Hospital |
| Principal Investigator: | Huang Wei Jian, MD, PhD | Wenzhou Medical College |
| Principal Investigator: | Sun Ying Xian, MD | China Medical University, China |
| Principal Investigator: | Li Guo Qing, MD | People's Hospital Of XinJiang Uygur Autonomous Region |
| Principal Investigator: | Yuan Zu Yi, MD | The First Hospital of Xian Jiao Tong University |
| Principal Investigator: | Wang Hai Chang, MD | Xijing Hospital |
| Principal Investigator: | Wang Yan, MD,PhD | Zhongshan Hospital Xiamen University |
| Principal Investigator: | Gao Chuan Yu, MD, PhD | Henan Provincial Hospital |
| Principal Investigator: | Wang Chun, MD, PhD | Peking University, Shen Zhen Hospital |
| Principal Investigator: | Yong Wang, MD, PhD | China-Japan Friendship Hospital |
More Information
No publications provided
| Responsible Party: | Johnson & Johnson Medical, China |
| ClinicalTrials.gov Identifier: | NCT00938119 History of Changes |
| Other Study ID Numbers: | CDS-200801 |
| Study First Received: | June 24, 2009 |
| Last Updated: | November 30, 2011 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Johnson & Johnson Medical, China:
|
Cardiovascular disease Diabetes |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Coronary Artery Disease Diabetes Mellitus Coronary Disease Myocardial Ischemia Heart Diseases |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013