Care China-Diabetes

NCT00938119 | Terminated DMC

• 1 other identifier: CDS-200801
• Study Type: observational
• Target: 1,603
• Locations: 1 country
• Sites: 46

Brief Summary

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.

Conditions

Cardiovascular Disease; Diabetes

Keywords

Cardiovascular disease; Diabetes

Outcome Measures

Primary Outcomes (1)

• MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months

  12 months

Secondary Outcomes (1)

• ARC (probable + definite) ST at 1-day, and 1 and 12 months

  12 months

Study Arms (1)

Diabetes patients with PCI

this is single group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Medical, China: lead

Study Sites (46)

Beijing Anzhen Hospital of the Capital University of Medical Science

Beijing, Beijing Municipality, 100029, China

Location

General Hospital of Armed Police Forces

Beijing, Beijing Municipality, 100039, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Beijing Tongren Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, 100730, China

Location

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, China

Location

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Location

Beijing Hospital

Beijing, Beijing Municipality, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

The General Hospital of the People's Liberation Army

Beijing, Beijing Municipality, China

Location

Xuan Wu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Location

China-Japan Friendship Hospital

Beijng, Beijing Municipality, 100029, China

Location

Zhongshan Hospital Xiamen University

Xiamen, Fujian, China

Location

Lanzhou University First Hospita

Lanzhou, Gansu, China

Location

Peking University, Shenzhen Hospital

Guangdong, Guangdong, China

Location

NanFang Hospital Affiliated to Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Guangdong General Hospital

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital,Sun Yat-Sen University

Guangzhou, Guangdong, China

Location

Peace Hospital

Shijiazhuang, Hebei, 050082, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, China

Location

The Second Affiliated Hospital of Jilin University

Changchun, Jilin, China

Location

The General Hospital of Shenyang Military Command

Shenyang, Liaoning, 110015, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, China

Location

The Affiliated Hospital Of Medical College Qingdao University

Qingdao, Shandong, China

Location

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai Jiaotong University School of Medicine affiliated Renji Hospital

Shanghai, Shanghai Municipality, China

Location

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, 030001, China

Location

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Xijing Hospital

Xian, Shanxi, China

Location

Tian Jin Chest Hospital

Tianjin, Tianjin Municipality, China

Location

Tianjin First Center Hospital

Tianjin, Tianjin Municipality, China

Location

People's Hospital Of XinJiang Uygur Autonomous Region

Urumuqi, Xinjiang, China

Location

Second Affiliated Hospital of Zhejiang University College of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Cardiovascular Institute & Fu Wai Hospital

Beijing, 100037, China

Location

General Hospital of Daqing Oilfield

Daqing, China

Location

Sir Run Run Shaw Hospital

Hangzhou, 310016, China

Location

Shandong Provincial Hospital

Jinan, 250021, China

Location

Shanghai Tenth People's Hospital of Tongji University

Shanghai, 200072, China

Location

Shengjing Hospital of China Medical University

Shenyang, 110004, China

Location

Teda International Cardiovascular Hospital

Tianjin, China

Location

The Affiliated Hospital of Medical College of Chinese Armed Police Forces

Tianjin, China

Location

The First Affiliated Hospital of Wenzhou Medical College

Wenzhou, 325000, China

Location

The First Hospital of Xian Jiao Tong University

Xi'an, 710061, China

Location

Biospecimen

Retention: NONE RETAINED

Diabetes patient

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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

  Chinese PLA General Hospital

  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 Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Du Zhi Min, MD

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Hou Yu Qing, MD

  Southern Medical University, China

  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, School of Medicine, Zhejiang University

  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

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Xu Biao, MD

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

• Li Lang, MD, PhD

  First Affiliated Hospital of 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 Affiliated 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 Central Hospital

  PRINCIPAL INVESTIGATOR

• Huang Wei Jian, MD, PhD

  First Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

• Sun Ying Xian, MD

  First Hospital of China Medical University

  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 People's Hospital

  PRINCIPAL INVESTIGATOR

• Wang Chun, MD, PhD

  Peking University, Shen Zhen Hospital

  PRINCIPAL INVESTIGATOR

• Yong Wang, MD, PhD

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: July 13, 2009
• Study Start: August 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2012
• Last Updated: June 28, 2013

Record last verified: 2011-07

Locations

CN (46)