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the Change of Cholesterol Efflux Capacity and Coronary Artery Disease in Real Clinical Practice

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ClinicalTrials.gov Identifier: NCT03389529
Recruitment Status : Not yet recruiting
First Posted : January 3, 2018
Last Update Posted : January 4, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Coronary Artery Disease Cardiovascular Mortality Myocardial Infarction Stroke

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 Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on the Relationship Between the Change of Cholesterol Efflux Capacity and the Prognosis of Coronary Artery Disease in Real Clinical Practice
Anticipated Study Start Date : March 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

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

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


Secondary Outcome Measures :
  1. the change of HDL-C subclasses (preβ1-HDL、HDL2、HDL3) [ Time Frame: before and 6-, 12-, 18-, 24- month after follow-up ]
    the change of HDL-C subclasses (preβ1-HDL、HDL2、HDL3)

  2. the concentration and activity of plasma LCAT [ Time Frame: before and 6-, 12-, 18-, 24- month after follow-up ]
    the concentration and activity of plasma LCAT

  3. coronary revascularization [ Time Frame: 24 months ]
    coronary revascularization

  4. heart failure [ Time Frame: 24 months ]
    heart failure

  5. cardiovascular mortality [ Time Frame: 24 months ]
    cardiovascular mortality

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

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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
First diagnosis of CAD through CAG
Criteria

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.

More Information

Responsible Party: Lu'an Municipal Hospital
ClinicalTrials.gov Identifier: NCT03389529     History of Changes
Other Study ID Numbers: CCECPCAD
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases