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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03473860
Recruitment Status : Not yet recruiting
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
First Affiliated Hospital of Jinan University
Information provided by (Responsible Party):
Lu'an Municipal Hospital

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.

Condition or disease
Coronary Artery Disease

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. the change of CEM [ Time Frame: before and 6-, 12-, 18-, 24- month after follow-up ]
    the change of CEM

Secondary Outcome Measures :
  1. coronary revascularization [ Time Frame: 24- months ]
    coronary revascularization

  2. heart failure [ Time Frame: 24- months ]
    heart failure

  3. all-cause mortality [ Time Frame: 24- months ]
    all-cause mortality

  4. cardiovascular mortality [ Time Frame: 24- months ]
    cardiovascular mortality

  5. non-fatal myocardial infarction [ Time Frame: 24- months ]
    non-fatal myocardial infarction

  6. non-fatal stroke [ Time Frame: 24- months ]
    non-fatal stroke

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
First diagnosis of CAD through CAG

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).

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Responsible Party: Lu'an Municipal Hospital Identifier: NCT03473860     History of Changes
Other Study ID Numbers: zjh2018315
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lu'an Municipal Hospital:
all-cause mortality
myocardial infarction
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases