UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039921 |
|---|---|
| Receipt number | R000045090 |
| Scientific Title | Feasibility of Comprehensive Cardiac CT for Diabetic Patients During Educational Admission |
| Date of disclosure of the study information | 2020/03/24 |
| Last modified on | 2023/03/27 09:09:33 |
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Basic information
Public title
Feasibility of Comprehensive Cardiac CT for Diabetic Patients During Educational Admission
Acronym
Cardiac CT for DM Patients
Scientific Title
Feasibility of Comprehensive Cardiac CT for Diabetic Patients During Educational Admission
Scientific Title:Acronym
Cardiac CT for DM Patients
Region
| Japan |
Condition
Condition
Diabetes mellitus needing educational admission
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Radiology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility of comprehensive cardiac CT to predict coronary plaque progression and cardiovascular events.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plaque amount assessed by follow up coronary CT angiography and major adverse coronary events (cardiac death, nonfatal myocardial infarction, and unstable angina pectoris) after 2-year period.
Key secondary outcomes
1. Frequency of significant stenosis, ischemia, and revascularization.
2. Relationship between parameters acquired from cardiac CT and FFR, IVUS, and OCT.
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
| 35 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Educational admission for type 2 diabetes mellitus.
2. No renal dysfunction (estimated GFR >=60).
3. Able to hold the breath.
Key exclusion criteria
1. Allergy to contrast medium.
2. Asthma.
3. Severe AV block.
Target sample size
500
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 Medicine
Zip code
1138421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
+81338133111
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 Medicine
Zip code
1138421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
+81338133111
Homepage URL
snfujimo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo 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
Hospital Ethics Committee of Juntendo University Hospital
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
+813358021584
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
| 2020 | Year | 03 | Month | 24 | 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 | 03 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing else
Management information
Registered date
| 2020 | Year | 03 | Month | 24 | Day |
Last modified on
| 2023 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045090
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| Registered date | File name |
| Research case data | |
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