UMIN-CTR Clinical Trial

Basic information
Public title	Clinical impact of extracellular volume fraction for coronary atherosclerosis in asymptomatic patients with diabetes on coronary CT angiography; a prospective observational study
Acronym	Clinical impact of extracellular volume fraction for coronary atherosclerosis in asymptomatic patients with diabetes on coronary CT angiography; a prospective observational study
Scientific Title	Clinical impact of extracellular volume fraction for coronary atherosclerosis in asymptomatic patients with diabetes on coronary CT angiography; a prospective observational study
Scientific Title:Acronym	Clinical impact of extracellular volume fraction for coronary atherosclerosis in asymptomatic patients with diabetes on coronary CT angiography; a prospective observational study
Region	Japan

Condition
Condition	Stable Coronary Artery Disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relationship between ECV in asymptomatic diabetic patients and the characteristics of coronary artery lesions and the prediction of cardiovascular events.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Factors related with ECV in asymptomatic diabetic patients (patient background factors, lesion findings on coronary CT)
Key secondary outcomes

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	30 years-old <=
Age-upper limit	110 years-old >=
Gender	Male and Female
Key inclusion criteria	No history of coronary artery disease, CKD(eGFR 60), contrast media allergy or asthma.. Patients must be 30 years of age or older with type 2 diabetes mellitus at the time consent is obtained. Patients who meet the above criteria.
Key exclusion criteria	(1) Patients with poor coronary CT images that are difficult to evaluate (2)Highly obese (BMI over 30 kg/m2) (3) After thoracotomy (4) Others who are judged by the principal investigator to be inappropriate as research subjects Cases that meet the above criteria will be excluded.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Shinichiro Middle name Last name Fujimoto
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Cardiovascular Biology and Medicine
Zip code	113-8431
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	snfujimo@juntendo.ac.jp

Public contact
Name of contact person	1st name Shinichiro Middle name Last name Fujimoto
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Cardiovascular Biology and Medicine
Zip code	113-8431
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	snfujimo@juntendo.ac.jp

Sponsor
Institute	Juntendo University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Self funding
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	Juntendo Clinical Research and Trial Center
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel	03-3814-5672
Email	kenkyu5858@juntendo.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	2021 Year 12 Month 15 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	2021 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date	2022 Year 01 Month 30 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Events that occur 2 years after the CT analysis.

Management information
Registered date	2021 Year 12 Month 15 Day
Last modified on	2021 Year 12 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052904