Low CETP ActivityINFINITYNCT01916512
Relationship Between CETP Deficiency and Atherosclerosis in Patients With Hyperalphalipoproteinemia
An observational study of Low CETP Activity and CETP Deficiency, run by Osaka University at 1 site in Japan.
Trial summary
The aim of this study is to determine whether high high density lipoprotein-cholesterol(HDL-C) level and low Cholesteryl Ester Transfer Protein(CETP) activity is atherogenic or not in subjects who received health checkups. Read more about this study
- Who is it for?
- Ages 40 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Low CETP Activity, CETP Deficiency, Hyperalphalipoproteinemia
- How many people
- 1,500 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2012to Mar 2016
- 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 40 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will explain about this study with the attached leaflet to the male and female examinees at the age of 40 and above who undergo annual health check up at Hiraga General Hospital in Akita Prefecture and obtain written consent to participate in the study. The written consents will be stored. The participant information will be made anonymous with sequential ID numbers. However the comparative lists of each participant and ID number will be stored in the locked shelf in case of disclosure requests from participants in future. The above will be conducted at Hiraga hospital and the samples will be sent to and measured to collect data in Osaka University. The analysis of data will be done at Osaka University and Akita University.
Who may be able to join
- Subjects who are at the age of 40 and above and undergo annual health check in Omagari area including Daisen city and Yokote city and who provide written informed consent.
Who cannot join
- Those who do not provide written informed consent.
- Those who are not able to take tests.
- Those who are regarded not adequate as subject of this study by their physicians.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Osaka University Graduate School of Medicine
Suita, Osaka, 565-0879
Shizuya Yamashita, MD, PhD, +81-6-6879-3633, shizu@cardiology.med.osaka-u.ac.jp
Shizuya Yamashita, MD, PhD
About this study
Official title: Investigation of Relationship Between Cholesteryl Ester Transfer Protein Deficiency and Carotid/Coronary Atherosclerosis in Patients With Hyperalphalipoproteinemia
The aim of this study is to determine whether high high density lipoprotein-cholesterol(HDL-C) level and low Cholesteryl Ester Transfer Protein(CETP) activity is atherogenic or not in subjects who received health checkups. We investigate the association between CETP activities and the severity of atherosclerosis assessed by intima-media thickness (IMT) and compare the atherogenic change between in subjects with high HDL-C level, low HDL-C level, high CETP activities and low CETP activities by examining the morbidity rate of atherogenic diseases, the rate of ischemic electrocardiography(ECG) change, Calc Score of artery from chest X-ray, Ankle Brachial Index/Pulse Wave Velocity and various serum atherogenic markers. And we also examine the correlation between normal lipid profile and concentration, activity and function of surface lipoprotein in subjects with variety of lipoprotein levels, including patients with hyper-LDL-cholesterolemia, hyper-HDL-cholesterolemia with low or no CETP activity, patients with high level of remnant cholesterol or hyperlipoproteinemia of apolipoprotein(Apo)B-48.
- Conditions
- Low CETP Activity, CETP Deficiency, Hyperalphalipoproteinemia, Hyper-LDL-cholesterolemia, High Level of Remnant Cholesterol
- Keywords
- CETP, HDL, LDL, apoB-100, apoB-48, remnants
- Medical subject headings
- Cholesteryl Ester Transfer Protein Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of Ischemic changes of ECG among subjects with low/high CETP mass/activity and HDL-C level
The difference of Ischemic changes of ECG was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of Calc Score of Aorta by Chest X-ray among subjects with low/high CETP mass/activity and HDL-C level
The difference of Calc Score of Aorta by Chest X-ray was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of Ankle Brachial Index (ABI) among subjects with low/high CETP mass/activity and HDL-C level
The difference of Ankle Brachial Index (ABI) was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of Pulse Wave Velocity (baPW) among subjects with low/high CETP mass/activity and HDL-C level
The difference of Pulse Wave Velocity (baPW) was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of IMT and Plaque Score of Carotid artery among subjects with low/high CETP mass/activity and HDL-C level
The difference of IMT and Plaque Score of Carotid artery was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of CETP activity between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
The difference of CETP activity was assessed between in those who do not satisfy any of these three conditions (normolipidemic subjects) and those who satisfy any of these three conditions (patients with dyslipidemia); LDL-C:100 mg/dl and above, HDL:80 mg/dl and above, TG:150 mg/dl and above.
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of Antioxidant activity between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
The difference of Antioxidant activity was assessed between normolipidemic subjects and patients with dyslipidemia;HDL from subjects' serum samples will be added to LDL with 2,2'-azobis(2-amidinopropane) dihydrochloride (AAPH).
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of Monocyte chemoattractant protein-1 (MCP-1) concentration between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
The difference of MCP-1 concentration was assessed between normolipidemic subjects and patients with dyslipidemia
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of Cholesterol efflux between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
The difference of Cholesterol efflux by HDL from macrophage was assessed between normolipidemic subjects and patients with dyslipidemia
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of Proteome analysis of lipoproteins between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
The difference of Proteome analysis of lipoproteins (HDL, LDL, remnant binding protein) was assessed between normolipidemic subjects and patients with dyslipidemia
Measured: participants will be followed for the duration of hospital stay（2 days）
Secondary outcomes (15)
Difference of Fasting blood glucose and HbA1c among subjects with low/high CETP mass/activity and HDL-C level
The difference of Fasting blood glucose and HbA1c was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of waist circumference among subjects with low/high CETP mass/activity and HDL-C level
The difference of waist circumference was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of Smoking habits, alcohol taking habits and fitness habits among subjects with low/high CETP mass/activity and HDL-C level
The difference of Smoking habits, alcohol taking habits and fitness habits was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of BMI among subjects with low/high CETP mass/activity and HDL-C level
The difference of BMI was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of Blood Pressure among subjects with low/high CETP mass/activity and HDL-C level
The difference of Blood Pressure was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of 75g glucose tolerance test and calculated homeostasis model assessment of insulin resistance (HOMA-IR) among subjects with low/high CETP mass/activity and HDL-C level
The difference of 75g glucose tolerance test and calculated homeostasis model assessment of insulin resistance (HOMA-IR) was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of Total Cholesterol(TC) among subjects with low/high CETP mass/activity and HDL-C level
The difference of Total Cholesterol(TC) was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of low density lipoprotein-cholesterol (LDL-C) among subjects with low/high CETP mass/activity and HDL-C level
The difference of low density lipoprotein-cholesterol (LDL-C) was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of triglyceride (TG) among subjects with low/high CETP mass/activity and HDL-C level
The difference of triglyceride (TG) was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of Serum adiponectin among subjects with low/high CETP mass/activity and HDL-C level
The difference ofSerum adiponectin was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of Apolipoprotein (apo)B-48 concentrations among subjects with low/high CETP mass/activity and HDL-C level
The difference of Apolipoprotein (apo)B-48 concentrations was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of Remnant lipoprotein (RemL-C) among subjects with low/high CETP mass/activity and HDL-C level
The difference of Remnant lipoprotein (RemL-C) was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of Lipoprotein Profile between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
The difference of Lipoprotein Profile analyzed by high performance liquid chromatography(HPLC) method was assessed between in those who do not satisfy any of these three conditions (normolipidemic subjects) and those who satisfy any of these three conditions (patients with dyslipidemia); LDL-C:100 mg/dl and above, HDL:80 mg/dl and above, TG:150 mg/dl and above.
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of apolipoprotein(apo)B-48 concentrations between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
The difference of apoB-48 concentrations was assessed between in normolipidemic subjects and in patients with dyslipidemia
Measured: participants will be followed for the duration of hospital stay（2 days）
Difference of Remnant lipoprotein (RemL-C) between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
The difference of RemL-C was assessed between in normolipidemic subjects and in patients with dyslipidemia
Measured: participants will be followed for the duration of hospital stay（2 days）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startFeb 2012
- Primary completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low CETP ActivityStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Shizuya Yamashita, MD, PhD, FAHA, FJCC, Study chair, Osaka University Graduate School of MedicineEtsuko Fushimi, MD, PhD, Study director, Hiraga General HospitalHiroshi Itoh, MD, PhD, Study director, Akita University Graduate School of MedicineNorimichi Nakajima, MD, Study director, Nakajima Naika ClinicYoshinobu Ikeda, MD, Study director, Ikeda ClinicYuji Matsuzawa, MD, PhD, Study director, Sumitomo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916512
- Sponsor's protocol ID
- INFINITY
- Acronym
- INFINITY
- Status last verified
- Aug 2013
- First submitted
- 22 Jul 2013
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Relationship Between Cholesteryl Ester Transfer Protein Deficiency and Carotid/Coronary Atherosclerosis in Patients With Hyperalphalipoproteinemia
- ClinicalTrials.gov ID
- NCT01916512
- Acronym / sponsor ID
- INFINITY / INFINITY
- Conditions
- Low CETP Activity, CETP Deficiency, Hyperalphalipoproteinemia, Hyper-LDL-cholesterolemia, High Level of Remnant Cholesterol
- Keywords
- CETP, HDL, LDL, apoB-100, apoB-48, remnants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Feb 2012
- Primary completion
- Mar 2016 (estimated)
- First posted
- 5 Aug 2013 (estimated)
- 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 aim of this study is to determine whether high high density lipoprotein-cholesterol(HDL-C) level and low Cholesteryl Ester Transfer Protein(CETP) activity is atherogenic or not in subjects who received health checkups. We investigate the association between CETP activities and the severity of atherosclerosis assessed by intima-media thickness (IMT) and compare the atherogenic change between in subjects with high HDL-C level, low HDL-C level, high CETP activities and low CETP activities by examining the morbidity rate of atherogenic diseases, the rate of ischemic electrocardiography(ECG) change, Calc Score of artery from chest X-ray, Ankle Brachial Index/Pulse Wave Velocity and various serum atherogenic markers. And we also examine the correlation between normal lipid profile and concentration, activity and function of surface lipoprotein in subjects with variety of lipoprotein levels, including patients with hyper-LDL-cholesterolemia, hyper-HDL-cholesterolemia with low or no CETP activity, patients with high level of remnant cholesterol or hyperlipoproteinemia of apolipoprotein(Apo)B-48.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will explain about this study with the attached leaflet to the male and female examinees at the age of 40 and above who undergo annual health check up at Hiraga General Hospital in Akita Prefecture and obtain written consent to participate in the study. The written consents will be stored. The participant information will be made anonymous with sequential ID numbers. However the comparative lists of each participant and ID number will be stored in the locked shelf in case of disclosure requests from participants in future. The above will be conducted at Hiraga hospital and the samples will be sent to and measured to collect data in Osaka University. The analysis of data will be done at Osaka University and Akita University.
Key inclusion criteria (1 listed)
- Subjects who are at the age of 40 and above and undergo annual health check in Omagari area including Daisen city and Yokote city and who provide written informed consent.
Key exclusion criteria (3 listed)
- Those who do not provide written informed consent.
- Those who are not able to take tests.
- Those who are regarded not adequate as subject of this study by their physicians.
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
Difference of Ischemic changes of ECG among subjects with low/high CETP mass/activity and HDL-C level
Time frame: participants will be followed for the duration of hospital stay（2 days）
The difference of Ischemic changes of ECG was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Difference of Calc Score of Aorta by Chest X-ray among subjects with low/high CETP mass/activity and HDL-C level
Time frame: participants will be followed for the duration of hospital stay（2 days）
The difference of Calc Score of Aorta by Chest X-ray was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Difference of Ankle Brachial Index (ABI) among subjects with low/high CETP mass/activity and HDL-C level
Time frame: participants will be followed for the duration of hospital stay（2 days）
The difference of Ankle Brachial Index (ABI) was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Difference of Pulse Wave Velocity (baPW) among subjects with low/high CETP mass/activity and HDL-C level
Time frame: participants will be followed for the duration of hospital stay（2 days）
The difference of Pulse Wave Velocity (baPW) was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Difference of IMT and Plaque Score of Carotid artery among subjects with low/high CETP mass/activity and HDL-C level
Time frame: participants will be followed for the duration of hospital stay（2 days）
The difference of IMT and Plaque Score of Carotid artery was assessed between in subjects with high CETP mass/activity and in those with low CETP mass/activity, and between in subjects with high HDL-C level and in those with low HDL-C level
Difference of CETP activity between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
Time frame: participants will be followed for the duration of hospital stay（2 days）
The difference of CETP activity was assessed between in those who do not satisfy any of these three conditions (normolipidemic subjects) and those who satisfy any of these three conditions (patients with dyslipidemia); LDL-C:100 mg/dl and above, HDL:80 mg/dl and above, TG:150 mg/dl and above.
Difference of Antioxidant activity between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
Time frame: participants will be followed for the duration of hospital stay（2 days）
The difference of Antioxidant activity was assessed between normolipidemic subjects and patients with dyslipidemia;HDL from subjects' serum samples will be added to LDL with 2,2'-azobis(2-amidinopropane) dihydrochloride (AAPH).
Difference of Monocyte chemoattractant protein-1 (MCP-1) concentration between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
Time frame: participants will be followed for the duration of hospital stay（2 days）
The difference of MCP-1 concentration was assessed between normolipidemic subjects and patients with dyslipidemia
Difference of Cholesterol efflux between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
Time frame: participants will be followed for the duration of hospital stay（2 days）
The difference of Cholesterol efflux by HDL from macrophage was assessed between normolipidemic subjects and patients with dyslipidemia
Difference of Proteome analysis of lipoproteins between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
Time frame: participants will be followed for the duration of hospital stay（2 days）
The difference of Proteome analysis of lipoproteins (HDL, LDL, remnant binding protein) was assessed between normolipidemic subjects and patients with dyslipidemia
15 secondary outcomes
Difference of Fasting blood glucose and HbA1c among subjects with low/high CETP mass/activity and HDL-C level
Time frame: participants will be followed for the duration of hospital stay（2 days）
Difference of waist circumference among subjects with low/high CETP mass/activity and HDL-C level
Time frame: participants will be followed for the duration of hospital stay（2 days）
Difference of Smoking habits, alcohol taking habits and fitness habits among subjects with low/high CETP mass/activity and HDL-C level
Time frame: participants will be followed for the duration of hospital stay（2 days）
Difference of BMI among subjects with low/high CETP mass/activity and HDL-C level
Time frame: participants will be followed for the duration of hospital stay（2 days）
Difference of Blood Pressure among subjects with low/high CETP mass/activity and HDL-C level
Time frame: participants will be followed for the duration of hospital stay（2 days）
Difference of 75g glucose tolerance test and calculated homeostasis model assessment of insulin resistance (HOMA-IR) among subjects with low/high CETP mass/activity and HDL-C level
Time frame: participants will be followed for the duration of hospital stay（2 days）
Difference of Total Cholesterol(TC) among subjects with low/high CETP mass/activity and HDL-C level
Time frame: participants will be followed for the duration of hospital stay（2 days）
Difference of low density lipoprotein-cholesterol (LDL-C) among subjects with low/high CETP mass/activity and HDL-C level
Time frame: participants will be followed for the duration of hospital stay（2 days）
Difference of triglyceride (TG) among subjects with low/high CETP mass/activity and HDL-C level
Time frame: participants will be followed for the duration of hospital stay（2 days）
Difference of Serum adiponectin among subjects with low/high CETP mass/activity and HDL-C level
Time frame: participants will be followed for the duration of hospital stay（2 days）
Difference of Apolipoprotein (apo)B-48 concentrations among subjects with low/high CETP mass/activity and HDL-C level
Time frame: participants will be followed for the duration of hospital stay（2 days）
Difference of Remnant lipoprotein (RemL-C) among subjects with low/high CETP mass/activity and HDL-C level
Time frame: participants will be followed for the duration of hospital stay（2 days）
Difference of Lipoprotein Profile between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
Time frame: participants will be followed for the duration of hospital stay（2 days）
Difference of apolipoprotein(apo)B-48 concentrations between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
Time frame: participants will be followed for the duration of hospital stay（2 days）
Difference of Remnant lipoprotein (RemL-C) between normolipidemic subjects and patients with dyslipidemia (including high HDL-C level)
Time frame: participants will be followed for the duration of hospital stay（2 days）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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.
Shizuya Yamashita, MD, PhD, FAHA, FJCC study chair
Osaka University Graduate School of Medicine
Etsuko Fushimi, MD, PhD study director
Hiraga General Hospital
Hiroshi Itoh, MD, PhD study director
Akita University Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low CETP Activity and CETP Deficiency, run by Osaka University at 1 site in Japan.
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 1 inclusion and 3 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 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Shizuya Yamashita, MD, PhD, FAHA, FJCC (+81-6-6879-3633, shizu@cardiology.med.osaka-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of Ischemic changes of ECG among subjects with low/high CETP mass/activity and HDL-C level (time frame: participants will be followed for the duration of hospital stay（2 days）). The study lists 10 primary outcomes in all. 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 15 Apr 2015.