Relationship Between CETP Deficiency and Atherosclerosis in Patients With Hyperalphalipoproteinemia

NCT ID: NCT01916512

Last Updated: 2015-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Low CETP Activity CETP Deficiency Hyperalphalipoproteinemia Hyper-LDL-cholesterolemia High Level of Remnant Cholesterol

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

1. Those who do not provide written informed consent.
2. Those who are not able to take tests.
3. Those who are regarded not adequate as subject of this study by their physicians.
Minimum Eligible Age

40 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Osaka University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shizuya Yamashita, MD, PhD, FAHA, FJCC

Role: STUDY_CHAIR

Osaka University Graduate School of Medicine

Etsuko Fushimi, MD, PhD

Role: STUDY_DIRECTOR

Hiraga General Hospital

Hiroshi Itoh, MD, PhD

Role: STUDY_DIRECTOR

Akita University Graduate School of Medicine

Norimichi Nakajima, MD

Role: STUDY_DIRECTOR

Nakajima Naika Clinic

Yoshinobu Ikeda, MD

Role: STUDY_DIRECTOR

Ikeda Clinic

Yuji Matsuzawa, MD, PhD

Role: STUDY_DIRECTOR

Sumitomo Hospital

Locations

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Osaka University Graduate School of Medicine

Suita, Osaka, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Shizuya Yamashita, MD, PhD, FAHA, FJCC

Role: CONTACT

+81-6-6879-3633

Daisaku Masuda, MD, PhD

Role: CONTACT

+81-6-6879-3633

Facility Contacts

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Shizuya Yamashita, MD, PhD

Role: primary

+81-6-6879-3633

Other Identifiers

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INFINITY

Identifier Type: -

Identifier Source: org_study_id

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