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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03389529
Enrollment
200
Registered
2018-01-03
Start date
2018-04-01
Completion date
2021-12-31
Last updated
2018-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Mortality, Coronary Artery Disease, Myocardial Infarction, Stroke

Brief 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.

Interventions

None listed

Sponsors

First Affiliated Hospital of Jinan University
CollaboratorOTHER
Lu'an Municipal Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
the change of cholesterol efflux capacitybefore and 6-, 12-, 18-, 24- month after follow-upthe change of cholesterol efflux capacity

Secondary

MeasureTime frameDescription
the concentration and activity of plasma LCATbefore and 6-, 12-, 18-, 24- month after follow-upthe concentration and activity of plasma LCAT
coronary revascularization24 monthscoronary revascularization
heart failure24 monthsheart failure
the change of HDL-C subclasses (preβ1-HDL、HDL2、HDL3)before and 6-, 12-, 18-, 24- month after follow-upthe change of HDL-C subclasses (preβ1-HDL、HDL2、HDL3)
non-fatal myocardial infarction24 monthsnon-fatal myocardial infarction
non-fatal stroke24 monthsnon-fatal stroke
cardiovascular mortality24 monthscardiovascular mortality

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026