Clinical trial NCT03473860: the Change of CEM and the Prognosis of Coronary Artery Disease in Real Clinical Practice
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: prognosis
all-cause mortality
myocardial infarction
stroke
Lead sponsor: Lu'an Municipal Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Jinan University
First posted: 2018-03-22
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: First diagnosis of CAD through CAG

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.

Eligibility criteria: 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).

Primary outcomes:
measure: the change of CEM
timeFrame: before and 6-, 12-, 18-, 24- month after follow-up
Secondary outcomes:
measure: coronary revascularization
timeFrame: 24- months
measure: heart failure
timeFrame: 24- months
measure: all-cause mortality
timeFrame: 24- months
measure: cardiovascular mortality
timeFrame: 24- months
measure: non-fatal myocardial infarction
timeFrame: 24- months
measure: non-fatal stroke
timeFrame: 24- months
Other outcomes:
Locations:
Study officials:
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