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

Coronary Artery Disease Clinical Trial

— CCEMPCAD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03473860
• Other study ID #: zjh2018315
• Status: Not yet recruiting
• First received: March 15, 2018
• Last updated: March 21, 2018
• Start date: April 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2018
• Source: Lu'an Municipal Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lu'an Municipal Hospital	First Affiliated Hospital of Jinan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of CEM	the change of CEM	before and 6-, 12-, 18-, 24- month after follow-up
Secondary	coronary revascularization	coronary revascularization	24- months
Secondary	heart failure	heart failure	24- months
Secondary	all-cause mortality	all-cause mortality	24- months
Secondary	cardiovascular mortality	cardiovascular mortality	24- months
Secondary	non-fatal myocardial infarction	non-fatal myocardial infarction	24- months
Secondary	non-fatal stroke	non-fatal stroke	24- months