UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association of Lecithin-cholesterol Acyltransferase Activity and Low-density Lipoprotein Heterogeneity with Atherosclerotic Cardiovascular Risk: A Pilot Longitudinal Study
Title of the study (Brief title)	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	Shigemasa Tani
Organization	Nihon University Hospital
Division name	Department of Cardiology
Address	1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo , Japan
TEL	03-3293-1711
Email	tanishigem@yahoo.co.jp

Public contact
Name of contact person	Shigemasa Tani
Organization	Nihon University Hospital
Division name	Department of Cardiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000037889