UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033228
Receipt No. R000037889
Scientific Title Association of Lecithin-cholesterol Acyltransferase Activity and Low-density Lipoprotein Heterogeneity with Atherosclerotic Cardiovascular Risk: A Pilot Longitudinal Study
Date of disclosure of the study information 2018/07/02
Last modified on 2018/12/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Association of Lecithin-cholesterol Acyltransferase Activity and Low-density Lipoprotein Heterogeneity with Atherosclerotic Cardiovascular Risk: A Pilot Longitudinal Study
Acronym LCAT activity and LDL-particle size
Scientific Title Association of Lecithin-cholesterol Acyltransferase Activity and Low-density Lipoprotein Heterogeneity with Atherosclerotic Cardiovascular Risk: A Pilot Longitudinal Study
Scientific Title:Acronym LCAT activity and LDL-particle size
Region
Japan

Condition
Condition The criterion for patient registration was the presence of one or more risk factors for atherosclerosis.
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study was designed as a hospital-based longitudinal study to investigate the relationship between the change in LCAT activity and change in LDL-particle size in subjects who were available for additional measurements one year after their participation in our previous study.
Basic objectives2 Others
Basic objectives -Others using a longitudinal study, we attempted to clarify hypothesis that elevation of LCAT activity is associated with an increase in the serum levels of TRL-related markers, involved in TG metabolism (i.e. TG, remnant particle-like cholesterol [RLP-C], apolipoprotein (apo) B, apo C-2, and apo C-3), and is thus involved in reduction of the LDL-particle size.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endo point was to evaluate the association of the absolute change in
LCAT activity with the change in LDL particle size, using a multilogistic
regression analysis
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria The criterion for patient registration was the presence of one or more risk factors for atherosclerosis.
Key exclusion criteria hepatic dysfunction (alanine aminotransferase and aspartate aminotransferase more than 2 times the upper limit of the normal values), known malignant disease, refusal to provide consent for participation in the study, or the diagnosis of acute coronary syndrome within 3 months prior to the study, and/or serum TG 400 mg/dL.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigemasa Tani
Organization Nihon University Hospital
Division name Department of Cardiology
Zip code
Address 1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo , Japan
TEL 03-3293-1711
Email tanishigem@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigemasa Tani
Organization Nihon University Hospital
Division name Department of Cardiology
Zip code
Address 1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo , Japan
TEL 03-3293-1711
Homepage URL
Email tanishigem@yahoo.co.jp

Sponsor
Institute Department of Cardiology, Nihon University Hospital
Institute
Department

Funding Source
Organization Department of Cardiology, Nihon University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Collecting patient data.

Management information
Registered date
2018 Year 07 Month 02 Day
Last modified on
2018 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037889

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.