UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050107 |
|---|---|
| Receipt number | R000057077 |
| Scientific Title | Coronary CT angiography for the patients after coronary artery stenting (prospective study) |
| Date of disclosure of the study information | 2023/01/23 |
| Last modified on | 2023/06/10 22:43:42 |
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Basic information
Public title
Coronary CT angiography for the patients after coronary artery stenting (prospective study)
Acronym
Coronary CT angiography for the patients after coronary artery stenting (prospective study)
Scientific Title
Coronary CT angiography for the patients after coronary artery stenting (prospective study)
Scientific Title:Acronym
Coronary CT angiography for the patients after coronary artery stenting (prospective study)
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the diagnostic accuracy of conventional and new reconstruction methods for the presence of in-stent restenosis (ISR), verified by invasive coronary angiography (ICA).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of CT angiography for the detection of ISR in ICA
(comparison between conventional and new reconstruction methods)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients needing the evaluation of in-stent stenotic grades
Key exclusion criteria
1 Patients with a history of coronary aortic bypass grafting
2 Patients having an allergy to contrast agent or contrast nephropathy
3 Patients with <30 mL/min/1.73m2 eGFR
4 Patients deemed by their doctor to be unsuitable to participate in the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Izawa |
Organization
Fujita Health University
Division name
Department of Cardiology
Zip code
470-1192
Address
1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-2312
izawa@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Kawai |
Organization
Fujita Health University
Division name
Department of Cardiology
Zip code
470-1192
Address
1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-2312
Homepage URL
hkawai@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Ichihara International Scholarship Foundation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University IRB comittie
Address
1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
Tel
0562-93-2312
irb-sys@fujita-hu.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
| 2023 | Year | 01 | Month | 23 | 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
| 2023 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To compare the diagnostic accuracy in coronary CT using conventional and new reconstruction methods in patients requiring assessment of coronary in-stent stenosis, using invasive coronary angiography findings as true.
Management information
Registered date
| 2023 | Year | 01 | Month | 23 | Day |
Last modified on
| 2023 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057077
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
