跳至主要内容
临床试验/NCT02351674
NCT02351674Unknown不适用

A Single Centre, Retrospective Cohort Study on Post Analysis on the Link Between the Clinical Heart Rate and Outcomes During PCI

Dandan Li0 个研究点目标入组 15,000 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
15,000
主要终点
Proportion of patients with composite events including CVD mortality, fatal/non-fatal MI, non-fatal sudden cardiac arrest, fatal/non-fatal stroke and malignant arrhythmia

研究概览

简要总结

The trial is a single centre, retrospective cohort, non-interventional study to be conducted in the department of cardiology, Chinese PLA General Hospital, Beijing, China. To evaluate the link between mean perioperative clinical heart rate and short-term composite outcomes during PCI among local CHD patients.

详细描述

The study requires those data including subjects aged from 20 to 80 year-old, diagnosed as coronary heart disease with records on mean clinical heart rate during PCI from 2009.1 to 2014.5 in the database from the department of cardiology, Chinese PLA General Hospital, Beijing. All 15,000 subjects' related data from the database will be collected.Once selected, 15,000 patients in the retrospective cohort will be divided into 4 groups according to their mean clinical resting heart rate during PCI. Group 1 will be defined as subjects' mean clinical resting heart rate ≤70 BPM, which will be set as baseline. Group 2 will be defined as subjects' mean clinical resting heart rate between 71 to 80 BPM. Group 3 will be defined as subjects' mean clinical resting heart rate between 81 to 90 BPM. Group 4 will be defined as subjects' mean clinical resting heart rate >90 BPM. The primary endpoint is to determine the link between the mean perioperative heart rate and short-term outcomes during PCI among local CHD patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients consecutive enrolled in Chinese PLA General Hospital from January 2009 to May 2014
  • Diagnosed as coronary heart disease with records on mean clinical heart rate during PCI .

排除标准

  • Inferior wall myocardial infarction (MI) history or/and acute inferior wall MI patients;
  • Dead within 3 days after admit into wards;
  • LVEF<30%;
  • Install a permanent pacemaker patients.

结局指标

主要结局

Proportion of patients with composite events including CVD mortality, fatal/non-fatal MI, non-fatal sudden cardiac arrest, fatal/non-fatal stroke and malignant arrhythmia

时间窗: During PCI

次要结局

  • Mean perioperative clinical heart rate(During PCI)
  • Clinical resting heart rate and heart rate variability(During PCI)

研究者

发起方
Dandan Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dandan Li

M.D.

Chinese PLA General Hospital

相似试验

Retrospective Cohort Study on Post Analysis on the... | 临床试验