UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046385 |
|---|---|
| Receipt number | R000052904 |
| Scientific Title | Clinical impact of extracellular volume fraction for coronary atherosclerosis in asymptomatic patients with diabetes on coronary CT angiography; a prospective observational study |
| Date of disclosure of the study information | 2021/12/15 |
| Last modified on | 2021/12/15 14:24:02 |
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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
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
snfujimo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052904
