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

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.

Study Overview

• Status: Unknown
• Conditions: Myocardial Infarction; Coronary Artery Disease; Stroke; Cardiovascular Mortality

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

First diagnosis of CAD through CAG

Description

Inclusion Criteria:

Signed informed consent; First diagnosis of CAD through CAG; aged 30-70.

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the change of cholesterol efflux capacity	the change of cholesterol efflux capacity	before and 6-, 12-, 18-, 24- month after follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the change of HDL-C subclasses (preβ1-HDL、HDL2、HDL3)	the change of HDL-C subclasses (preβ1-HDL、HDL2、HDL3)	before and 6-, 12-, 18-, 24- month after follow-up
the concentration and activity of plasma LCAT	the concentration and activity of plasma LCAT	before and 6-, 12-, 18-, 24- month after follow-up
coronary revascularization	coronary revascularization	24 months
heart failure	heart failure	24 months
cardiovascular mortality	cardiovascular mortality	24 months
non-fatal myocardial infarction	non-fatal myocardial infarction	24 months
non-fatal stroke	non-fatal stroke	24 months

Collaborators and Investigators

• Sponsor: Lu'an Municipal Hospital
• Collaborators: First Affiliated Hospital of Jinan University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: December 27, 2017
• First Submitted That Met QC Criteria: December 27, 2017
• First Posted (Actual): January 3, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2018
• Last Update Submitted That Met QC Criteria: March 15, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CCECPCAD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No