UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042782 |
|---|---|
| Receipt number | R000048703 |
| Scientific Title | Prospective registry study of primary dyslipidemia |
| Date of disclosure of the study information | 2020/12/20 |
| Last modified on | 2020/12/18 18:53:10 |
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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
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/
enustasam@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048703
