UMIN-CTR Clinical Trial

Basic information
Public title	Prospective registry study of primary dyslipidemia
Acronym	PROLIPID
Scientific Title	Prospective registry study of primary dyslipidemia
Scientific Title:Acronym	PROLIPID
Region	Japan

Condition
Condition	Homozygous familial hypercholesterolemia (homo-FH) Heterozygous familial hypercholesterolemia (hetero-FH) Type III Hyperlipoproteinemia Familial chylomicronemia Sitosterolemia Cerebrotendinous xanthomatosis Lecithin cholesterol acyltransferase (LCAT) deficiency Tangier disease Abetalipoproteinemia
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The objectives of this registry are to describe natural cause and clinical practice including treatment of primary dyslipidemia, and to provide reliable information on the type of practice performed and the prognosis of patients in Japan.
Basic objectives2	Others
Basic objectives -Others	Patient Registry
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of adverse outcomes in patients with primary dyslipidemia [Through study completion]
Key secondary outcomes	All-cause mortality [Through study completion]

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Clinical and/or genetic diagnosis of the following Primary dyslipidemia: Homozygous familial hypercholesterolemia (homo-FH) Heterozygous familial hypercholesterolemia (hetero-FH) Type III Hyperlipoproteinemia Familial chylomicronemia Sitosterolemia Cerebrotendinous xanthomatosis Lecithin cholesterol acyltransferase (LCAT) deficiency Tangier disease Abetalipoproteinemia
Key exclusion criteria	Patients who refused to consent
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Mariko Middle name Last name Shiba
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Molecular Pathogenesis
Zip code	564-8565
Address	6-1 Kishibeshin-machi, Suita, Osaka
TEL	06-6170-1070
Email	mshiba@ncvc.go.jp

Public contact
Name of contact person	1st name Masatsune Middle name Last name Ogura
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Molecular Innovation in Lipidology
Zip code	564-8565
Address	6-1 Kishibeshin-machi, Suita, Osaka
TEL	06-6170-1070
Homepage URL	https://nanbyo-lipid.com/prolipid/
Email	enustasam@ncvc.go.jp

Sponsor
Institute	National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	National Cerebral and Cardiovascular Center
Address	6-1 Kishibeshin-machi, Suita, Osaka
Tel	06-6170-1070
Email	rec-office-ac@ncvc.go.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	2020 Year 12 Month 20 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	Enrolling by invitation
Date of protocol fixation	2015 Year 01 Month 21 Day
Date of IRB	2015 Year 02 Month 03 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study started at August 1, 2015.

Management information
Registered date	2020 Year 12 Month 18 Day
Last modified on	2020 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048703