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临床试验/NCT02667548
NCT02667548Unknown不适用

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

Shengjing Hospital0 个研究点目标入组 7,000 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
7,000
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. By consecutively recruiting PCI patients in a large-scale hospital in in Northeast China,this study will examine various real-life factors, that may affect patients recovery after the procedure. Practical guidelines, appropriateness criteria and quality evaluative system for PCI will be established based on the findings, to 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. Practical and applied knowledge from large unselected population is needed to guide practice for quality improvement.

This study will enroll patients undergoing PCI in a large-scale hospital in in Northeast China. At study entry, participants will be interviewed during their index hospitalization, to collect information about symptoms, functioning, quality of life, and medical care. Demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained professional abstractors. 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. At 1 month, 6 month, 12 month, 3 year and 5 year after discharge, participants will return to the clinic for follow up visits, a face-to-face interview will be conducted to get information about clinical events, symptoms, functioning, quality of life, and medical care during the recovery period. If participants can not return to the clinic for follow up visits,a telephone interview will be conducted to get the related information. Before discharge,, blood sample will be collected. Participants' blood samples will be stored for future biologic and genetic studies. This study will examine various real-life factors that may affect patients recovery after PCI, including patients' characteristics and treatment measures. Practical guidelines, quality evaluative system, and appropriateness criteria will be established based on the findings, to improve patients outcomes in future finally.

研究设计

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

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

  • Previously enrolled in the R-PUSH study

结局指标

主要结局

Percentage of Participants with Major adverse cardiovascular events (MACE)

时间窗: 5 year

Composite of major adverse cardiovascular events (MACE) including cardiac death, non-fatal AMI, coronary revascularization procedure, or ischemic stroke

次要结局

  • Percentage of Participants with all-cause death(5 year)
  • Percentage of Participants with coronary revascularization procedure(5 year)
  • Symptoms status as assessed by SAQ(5 year)
  • Stress as assessed by PSS-4(5 year)
  • Percentage of Participants with cardiac death(5 year)
  • Percentage of Participants with non-fatal AMI(5 year)
  • Percentage of Participants with Cardiac Re-admission(5 year)
  • Percentage of Participants with Adherence to medications for secondary prevention(5 year)
  • Percentage of Participants with ischemic stroke(5 year)
  • Number of Participants who quit smoking(5 year)
  • Quality of life as assessed by EQ-5D(5 year)
  • Depression as assessed by PHQ-8(5 year)

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

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