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临床试验/NCT03473860
NCT03473860Unknown不适用

Study on the Relationship Between the Change of Total Cholesterol Content of Erythrocyte Membranes (CEM) and the Prognosis of Coronary Artery Disease in Real Clinical Practice

Lu'an Municipal Hospital0 个研究点目标入组 200 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
主要终点
the change of CEM

研究概览

简要总结

The purpose of this study is to investigate the change of total cholesterol content of erythrocyte membranes (CEM) in patients with coronary artery disease treated with secondary prevention drugs, and the correlation with the prognosis.

详细描述

In this clinical trial, plasma samples, the red cells and associated clinical data of patients with coronary artery disease were collected from Department of Cardiology of Lu'an Shili Hospital and the First Affiliated Hospital of Jinan University. Blood samples collected from all the participants at baseline (prior to the follow-up) and the time points of follow-up were placed into ordinary test tubes and stored at 4°C for less than 4 hours. After centrifuged, plasma and erythrocyte membranes was separated and stored at -80°C. The change of total cholesterol content of erythrocyte membranes (CEM) was measured. A follow-up form was designed according to the research purpose and discussed among the team members. The follow-up was performed through telephone by the trained investigators with good communication skills and knowledge on the diagnosis and treatment of coronary artery disease. Patients were followed up every six months from the day of discharge. The results of the follow-up were entered into the database, a process that was carried out by a designated person and double-checked by an independent person. The primary clinical endpoints were composite atherosclerotic cardiovascular disease outcomes, defined as nonfatal myocardial infarction, nonfatal stroke, or cardiovascular mortality. Secondary clinical endpoints were revascularization, including percutaneous coronary intervention and coronary artery bypass grafting, and Class IV heart failure requiring hospitalization.

研究设计

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

入排标准

年龄范围
45 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Signed informed consent;
  • First diagnosis of CAD through CAG;
  • Aged 45-70.

排除标准

  • Patients with severe liver or kidney damage;
  • Taking statins within the last 3 months;
  • Patients who had been diagnosed with CAD and treated with oral medication;
  • Chronic diseases of the blood system;
  • Familial hyperlipidemia patients;
  • Patients combining autoimmune disease;
  • Patients combining acute infectious disease;
  • Patients who undertaken surgery or injury;
  • Patients who combining cancer;
  • Patients who taking glucocorticoid replacement therapy;
  • Abnormal red blood cell (RBC) count (M: <4.0 or >5.5 × 1012/L; F: <3.5 or >5.0 × 1012/L) or abnormal hemoglobin (M: <120 or >160 g/L; F: <110 or >150 g/L).

结局指标

主要结局

the change of CEM

时间窗: before and 6-, 12-, 18-, 24- month after follow-up

the change of CEM

次要结局

  • non-fatal myocardial infarction(24- months)
  • coronary revascularization(24- months)
  • heart failure(24- months)
  • all-cause mortality(24- months)
  • cardiovascular mortality(24- months)
  • non-fatal stroke(24- months)

研究者

发起方
Lu'an Municipal Hospital
申办方类型
Other
责任方
Sponsor

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