跳至主要内容
临床试验/NCT02667028
NCT02667028Unknown不适用

Retrospective Evaluation of Prognosis of Pci Patients Using Network Data in SHengjing Hospital of China Medical University

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
3,000
试验地点
1
主要终点
Percentage of Participants with Major adverse cardiovascular events (MACE)

研究概览

简要总结

Coronary heart disease (CHD) has a serious health threaten to population. PCI is a well-proved measure in CHD management. However, the knowledge about the real-life PCI use and how evidence-based therapies in routine clinical practice is limited. In a large-scale hospital in Northeast China, the investigators will examine various factors of 3007 consecutive PCI inpatient cases from January 1, 2010 to October 31, 2014. The medical records will be reviewed and abstracted to evaluate the clinical treatment pattern and outcomes. Basic data and innovative evidence will accelerate evidence-based clinical practice, and improve patients' outcomes in future finally.

详细描述

Cardiovascular disease (CVD) is a major concern in public health in China. Relatively limited information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice. In addition, little information is available about the practical and applied knowledge from large unselected population and is used to guide practice for quality improvement.

To investigate the treatment pattern and outcomes of PCI in a real-world clinical setting, 3007 consecutive PCI cases will be selected from January 1, 2010 to October 31, 2014, in a large-scale hospital in Northeast China.At first, the investigators identified all PCI patients from PACS (Picture Archiving and Communication Systems) of the interventional imaging data from January 1, 2010 to October 31, 2014 and assigned each case a unique study ID. Then, the investigators abstracted comprehensive clinical data and procedural data. Comprehensive clinical data came from electronic medical records, including patient demographic characteristics, past cardiac and noncardiac history, patient clinical characteristics on hospital admission, laboratory measurements, procedure-related complications and use of cardiac medications during the index hospitalization and at discharge. CAG imaging will be reviewed by 2 cardiologists through PACS. Other Procedural data, including stent type, total stent length and so on, came from operation records of PCI cases finished by operators. The first clinical follow-up was assessed in October 2015 by direct hospital visits or phone interviews of patient's general practitioner/cardiologist, patient himself, or his family for all cases. A secondary clinical follow-up will be assessed individually if the three-year-follow-up of the patient was available. A third clinical follow-up will be assessed individually if the five-year-follow-up of the patient was available. All events were obtained from the patients' medical records. If these data were unavailable, status was ascertained by a telephone call to the patient's referring hospital physician. All events were adjudicated and classified by 2 cardiologists. By characterizing differences in patients' features, comparing the use of medications and procedures, and examining the outcomes, we'll define the gaps between clinical practice and guidelines to evaluated the treatment pattern and outcomes. New knowledge will be generated about PCI management to provide evidence for clinical guidelines, and to improve patients prognosis in future finally.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitalized patients undergoing a percutaneous coronary intervention (PCI) for coronary lesions.

排除标准

  • 未提供

结局指标

主要结局

Percentage of Participants with Major adverse cardiovascular events (MACE)

时间窗: 5 years

Composite of major adverse cardiovascular events (MACE) includes cardiac death, non-fatal AMI, coronary revascularization procedure.

次要结局

  • Percentage of Participants with adherence to medications for secondary prevention(5 years)
  • Percentage of Participants with all-cause death(5 years)
  • Percentage of Participants with cardiac death(5 years)
  • Percentage of Participants with non-fatal AMI(5 years)
  • Percentage of Participants with Cardiac Re-admission(5 years)
  • Percentage of Participants with coronary revascularization(5 years)
  • Percentage of Participants with stroke(5 years)
  • Number of Participants who quit smoking(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

YU Tong-tong

attending physician

Shengjing Hospital

研究点 (1)

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