UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038210
Receipt number R000043552
Scientific Title The Hokuriku Plus Familial Hypercholesterolemia Registry Study
Date of disclosure of the study information 2020/04/01
Last modified on 2022/04/21 14:25:36

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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 or person

Institute

Kanazawa University Hospital Department of Cardiology

Institute

Department

Personal name



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

Enrolling by invitation

Date of protocol fixation

2019 Year 09 Month 08 Day

Date of IRB

2020 Year 01 Month 22 Day

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

2022 Year 04 Month 21 Day



Link to view the page

Value
https://center6.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