Coronary Artery DiseaseCCEMPCADNCT03473860
the Change of CEM and the Prognosis of Coronary Artery Disease in Real Clinical Practice
An observational study of Coronary Artery Disease, run by Lu'an Municipal Hospital.
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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: First diagnosis of CAD through CAG
Who may be able to join
- Signed informed consent;
- First diagnosis of CAD through CAG;
- Aged 45-70.
Who cannot join
- 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;
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- 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).
About this study
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
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Keywords
- prognosis, all-cause mortality, myocardial infarction, stroke
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of CEM
the change of CEM
Measured: before and 6-, 12-, 18-, 24- month after follow-up
Secondary outcomes (6)
coronary revascularization
coronary revascularization
Measured: 24- months
heart failure
heart failure
Measured: 24- months
all-cause mortality
all-cause mortality
Measured: 24- months
cardiovascular mortality
cardiovascular mortality
Measured: 24- months
non-fatal myocardial infarction
non-fatal myocardial infarction
Measured: 24- months
non-fatal stroke
non-fatal stroke
Measured: 24- months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start1 Apr 2018 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lu'an Municipal Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Jinan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473860
- Sponsor's protocol ID
- zjh2018315
- Acronym
- CCEMPCAD
- Status last verified
- Mar 2018
- First submitted
- 15 Mar 2018
- Last updated
- 22 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03473860
- Acronym / sponsor ID
- CCEMPCAD / zjh2018315
- Conditions
- Coronary Artery Disease
- Keywords
- prognosis, all-cause mortality, myocardial infarction, stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lu'an Municipal HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Jinan University
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- First diagnosis of CAD through CAG
Key inclusion criteria (3 listed)
- Signed informed consent;
- First diagnosis of CAD through CAG;
- Aged 45-70.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the change of CEM
Time frame: before and 6-, 12-, 18-, 24- month after follow-up
the change of CEM
6 secondary outcomes
coronary revascularization
Time frame: 24- months
heart failure
Time frame: 24- months
all-cause mortality
Time frame: 24- months
cardiovascular mortality
Time frame: 24- months
non-fatal myocardial infarction
Time frame: 24- months
non-fatal stroke
Time frame: 24- months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Lu'an Municipal Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of CEM (time frame: before and 6-, 12-, 18-, 24- month after follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.