UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of lipid profile in the general population with no history of cardiovascular disease
Acronym	Investigation of lipid profile in the general population with no history of cardiovascular disease
Scientific Title	Investigation of lipid profile in the general population with no history of cardiovascular disease
Scientific Title:Acronym	Investigation of lipid profile in the general population with no history of cardiovascular disease
Region	Japan

Condition
Condition	none
Classification by specialty	Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assessment of cardiovascular risk factors in the current general population
Basic objectives2	Others
Basic objectives -Others	Comparison with cardiovascular risk factors in a population with heart disease
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Triglycerides total cholesterol HDL/LDL cholesterol fatty acid quadrants including EPA/AA ratio Lp(a) HbA1c high sensitivity CRP
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients over 20 years old who have undergone our physical examination and have no history of cardiovascular disease (myocardial infarction, angina pectoris, cerebral infarction, aortic dissection, aortic aneurysm, lower extremity artery occlusion).
Key exclusion criteria	History of cardiovascular disease Taking medications or supplements containing EPA/ DHA Persons who are deemed by their physician to be inappropriate to participate in the program
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Doi Middle name Last name Masayuki
Organization	Kagawa Prefectural Central Hospital
Division name	Cardiology
Zip code	760-8557
Address	1-2-1 Asahi-machi, Takamatsu, Kagawa, Japan
TEL	087-811-3333
Email	mdoimd@gmail.com

Public contact
Name of contact person	1st name Takagi Middle name Last name Wataru
Organization	Kagawa Prefectural Central Hospital
Division name	Cardiology
Zip code	760-8557
Address	1-2-1 Asahi-machi, Takamatsu, Kagawa, Japan
TEL	087-811-3333
Homepage URL
Email	t_wataru1206@yahoo.co.jp

Sponsor
Institute	Kagawa Prefectural Central Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kagawa Prefectural Central Hospital
Address	1-2-1 Asahi-machi, Takamatsu, Kagawa, Japan
Tel	087-811-3333
Email	chuobyoin@pref.kagawa.lg.jp

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	2022 Year 10 Month 07 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Open public recruiting
Date of protocol fixation	2022 Year 07 Month 25 Day
Date of IRB	2022 Year 07 Month 25 Day
Anticipated trial start date	2022 Year 07 Month 25 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Serum EPA/AA ratio is associated with cardiovascular diseases such as angina pectoris and myocardial infarction, and a decrease in serum EPA/AA ratio has been reported as a risk factor for cardiovascular diseases. In the general population, a decrease in serum EPA/AA ratio is presumed to be caused by a decrease in seafood intake among Japanese, but there have been few reports since then, although the Hisayama study published in 2005 can be confirmed. We will measure the current serum EPA/AA ratio and compare it with previous results and data from patients with a history of cardiovascular disease.

Management information
Registered date	2022 Year 10 Month 07 Day
Last modified on	2022 Year 10 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055968