UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040198 |
|---|---|
| Receipt number | 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 | 2022/04/21 14:30:35 |
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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
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
ht240z@sa3.so-net.ne.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
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
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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 17 | Day |
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
| 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=R000045838
