NCT03389529

the Change of Cholesterol Efflux Capacity and Coronary Artery Disease in Real Clinical Practice

Study on the Relationship Between the Change of Cholesterol Efflux Capacity and the Prognosis of Coronary Artery Disease in Real Clinical Practice

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Lu'an Municipal Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the change of cholesterol efflux capacity in patients with coronary artery disease treated with secondary prevention drugs, and the correlation with the prognosis.

Detailed description

In this clinical trial, serum samples 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. The blood was then centrifuged, and serum was separated and stored at -80°C. The change of cholesterol efflux capacity, HDL-C subclasses (preβ1-HDL, HDL2, HDL3), the concentration and activity of plasma LCAT were 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.

Conditions

• Coronary Artery Disease
• Cardiovascular Mortality
• Myocardial Infarction
• Stroke

Timeline

• Start date: 2018-04-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2018-01-03
• Last updated: 2018-03-16