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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038210
Receipt No. R000043552
Scientific Title The Hokuriku Plus Familial Hypercholesterolemia Registry Study
Date of disclosure of the study information 2020/04/01
Last modified on 2019/10/05

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Basic information
Public title The Hokuriku Plus Familial Hypercholesterolemia Registry Study
Acronym The Hokuriku Plus FH Registry Study
Scientific Title The Hokuriku Plus Familial Hypercholesterolemia Registry Study
Scientific Title:Acronym The Hokuriku Plus FH Registry Study
Region
Japan

Condition
Condition Familial Hypercholesterolemia
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 We aim to improve the prognosis of the patients with FH.
Basic objectives2 Others
Basic objectives -Others investigation for thier prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes new ASCVD events
Key secondary outcomes LDL cholesterol, seondary ASCVD events, occurrence of other diseases (hypertension, diabetes, malignancies).

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 Patients diagnosed with familial hypercholesterolemia per the criteria of the Japa Atherosclerosis Society
Key exclusion criteria Patients whose doctors in charge consider him/her inappropriate to participate
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Hayato
Middle name
Last name Tada
Organization Kanazawa University Hospital
Division name Department of Cardiology
Zip code 920-8641
Address 13-1 Takara-machi, Kanazawa, Japan
TEL 0762652000
Email ht240z@sa3.so-net.ne.jp

Public contact
Name of contact person
1st name Hayato
Middle name
Last name Tada
Organization Kanazawa University Hospital
Division name Department of Cardiology
Zip code 920-8641
Address 13-1 Takara-machi, Kanazawa, Japan
TEL 0762652000
Homepage URL
Email ht240z@sa3.so-net.ne.jp

Sponsor
Institute Kanazawa University Hospital Department of Cardiology
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
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 Innovative Clinical Research Center, Kanazawa University
Address 13-1 Takara-machi, Kanazawa, Japan
Tel 0762652000
Email hpsangak@adm.kanazawa-u.ac.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 04 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Basic variables include the date of birth, gender, height, body weight. Physical findings include cutaneous xanthomas, Achilles tendon thickness, arcus corneae, the thick ness of Achilles tendon. Family history includes the family history of premature coronary artery disease, or that of FH. Complications include hypertension, diabetes, any malignancies, ischemic or hemorrhagic stroke, or any unknown critical status. Genetic analyses include the presence and type of pathogenic mutation in FH-associated gene. Prior ASCVD include carotid atherosclerosis, coronary atherosclerosis, peripheral artery diseases, or aortic valve stenosis. Laboratory data include blood counts, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, lipoprotein(a), apolipoproteins, plasma glucose, HbA1c, AST, ALT, ALP, LDH, BUN, Cr, uric acid, Na, K, Cl, CRP, urinalysis. Events include new onset of ASCVD(carotid atherosclerosis, coronary atherosclerosis, PAD, aortic valve stenosis), complications including hypertension, diabetes, any malignancies, ischemic or hemorrhagic stroke, or any unknown critical status.

Management information
Registered date
2019 Year 10 Month 05 Day
Last modified on
2019 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043552

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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