UMIN-CTR Clinical Trial

Basic information
Public title	Development of risk indicators for vascular diseases with multi-omics and non-invasive blood flow analysis
Acronym	Development of risk indicators for vascular diseases with multi-omics and non-invasive blood flow analysis
Scientific Title	Development of risk indicators for vascular diseases with multi-omics and non-invasive blood flow analysis
Scientific Title:Acronym	Development of risk indicators for vascular diseases with multi-omics and non-invasive blood flow analysis
Region	Japan

Condition
Condition	1.Diabetes and its complications 2.Vascular diseases
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism Nephrology Ophthalmology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To develop risk indicators related to the onset, severity and prognosis of diabetic complications and various vascular diseases
Basic objectives2	Others
Basic objectives -Others	To develop an artificial intelligence algorithm to predict the risk of various vascular diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Factors associated with the development and progression of various vascular diseases
Key secondary outcomes	1.Factors associated with the presence, disease subtype, severity, and treatment response of various vascular diseases 2.Factors associated with ocular blood flow 3.Factors associated with the levels of HbA1c 4.Factors associated with nail bed capillaries 5.Factors associated with the degree of oxidative stress

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Diabetes and its complications 2. Fundus diseases other than diabetic retinopathy 3. Uveitis 4. Lifestyle-related diseases other than diabetes and obesity without diabetes 5. Cardio-cerebrovascular disease 6. Cataract, epiretinal membrane, macular hole, hypertension, dyslipidemia without the above diseases
Key exclusion criteria	Patients who disagreed with participating this study.
Target sample size	7000

Research contact person
Name of lead principal investigator	1st name Toru Middle name Last name Nakazawa
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Ophthalmology
Zip code	980-8574
Address	Seiryo-cho Aoba-ku Sendai-shi Miyagi-ken
TEL	022-717-7294
Email	ntoru@oph.med.tohoku.ac.jp

Public contact
Name of contact person	1st name Masayuki Middle name Last name Yasuda
Organization	Tohoku University Hospital
Division name	Department of Ophthalmology
Zip code	980-8574
Address	Seiryo-cho Aoba-ku Sendai-shi Miyagi-ken
TEL	022-717-7294
Homepage URL
Email	myasuda@oph.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethics Committee Tohoku University Graduate School of Medicine
Address	2-1, Seiryo-cho, Aoba-ku, Sendai-shi, Miyagi-ken
Tel	022-717-8007
Email	med-kenkyo@grp.tohoku.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 05 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 04 Month 20 Day
Date of IRB
Anticipated trial start date	2020 Year 04 Month 21 Day
Last follow-up date	2030 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We aim to identify biomarkers of vascular diseases in various organs throughout the body, mainly for diabetic complications. We will analyze biosamples and non-invasive vascular imaging data for this purpose.

Management information
Registered date	2020 Year 03 Month 12 Day
Last modified on	2020 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045391