the Change of CEM and the Prognosis of Coronary Artery Disease in Real Clinical Practice

• Conditions: Coronary Artery Disease

• Registration Number: NCT03473860
• Lead Sponsor: Lu'an Municipal Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2018-03
• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-21
• Last Update Submitted: 2018-03-21
• Study First Posted: 2018-03-22
• Last Update Posted: 2018-03-22
• Study Start: 2018-04-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• 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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the change of CEM	before and 6-, 12-, 18-, 24- month after follow-up	the change of CEM

Secondary Outcome Measures

Name	Time	Method
coronary revascularization	24- months	coronary revascularization
cardiovascular mortality	24- months	cardiovascular mortality
non-fatal myocardial infarction	24- months	non-fatal myocardial infarction
heart failure	24- months	heart failure
all-cause mortality	24- months	all-cause mortality
non-fatal stroke	24- months	non-fatal stroke