UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040198
Receipt No. R000045838
Scientific Title Effects of Artificial Intelligence (AI)-Supported Automated Nutritional Intervention on LDL cholesterol Control in Patients with familial hypercholesterolemia (iSTART-FH)
Date of disclosure of the study information 2020/09/01
Last modified on 2020/04/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of Artificial Intelligence (AI)-Supported Automated Nutritional Intervention on LDL cholesterol Control in Patients with familial hypercholesterolemia (iSTART-FH)
Acronym Effects of Artificial Intelligence (AI)-Supported Automated Nutritional Intervention on LDL cholesterol Control in Patients with familial hypercholesterolemia (iSTART-FH)
Scientific Title Effects of Artificial Intelligence (AI)-Supported Automated Nutritional Intervention on LDL cholesterol Control in Patients with familial hypercholesterolemia (iSTART-FH)
Scientific Title:Acronym Effects of Artificial Intelligence (AI)-Supported Automated Nutritional Intervention on LDL cholesterol Control in Patients with familial hypercholesterolemia (iSTART-FH)
Region
Japan

Condition
Condition Familial Hypercholesterolemia
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigated the efficacy of Artificial Intelligence (AI)-Supported Automated Nutritional Intervention on LDL cholesterol Control in Patients with familial hypercholesterolemia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Absolute change of LDL-C from baseline (at 12 months)
Key secondary outcomes Fasting glucose
Cost
Blood pressure
Serum lipids (TCHO, TG, HDL-C)
Urin albmin
New onset of diabetes
Changes in lipid-lowering therapies
Frequency of use of application
Absolute LDL-C change due to the change of nutritional intake

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Nutritional intervention through amartphnoe application(for 12 month)
Interventions/Control_2 Standard nutritional counseling
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

Not applicable
Gender Male and Female
Key inclusion criteria who is applicable to all of those
Pateints with FH regarldess of medical therapies, gender, and ASCVD
Disgnostic criteria is used by Japan Atherosclerosis Society 2017
LDL-C 100 mg/dL or over
age 20 years or over
who can used smartphone app
who provide written informed consent to this study
Key exclusion criteria who is applicable to one of those
diabetes, malignant hypertension, secondary hypertension
under insulin therapy
Female with pregnancy or expected
eGFR< 45ml/min/1.73m2
severe Liver dysfunction
within 1 year from myocardial infarction or stroke
allergy and/or nuder steroid
pancreatitis (active or history)
under treatment of malignancies
Patients whose doctors in charge consider him/her inappropriate to participate
Target sample size 60

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
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
TEL 0762652000
Homepage URL
Email ht240z@sa3.so-net.ne.jp

Sponsor
Institute Kanazawa University Hospital
Institute
Department

Funding Source
Organization Department of Cardiovascular Medicine, Kanazawa University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization JAPAN

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

IRB Contact (For public release)
Organization IRB of the Kanazawa University
Address 13-1 Takara-machi, Kanazawa
Tel 0762652832
Email rinri@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 金沢大学附属病院(石川県)

Other administrative information
Date of disclosure of the study information
2020 Year 09 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
2020 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 19 Day
Last modified on
2020 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045838

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.