UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051754 |
|---|---|
| Receipt number | R000057753 |
| Scientific Title | Prognostic study of coronary CT angiography for the patients with coronary artery stenting |
| Date of disclosure of the study information | 2023/07/30 |
| Last modified on | 2025/07/31 09:34:04 |
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Basic information
Public title
Prognostic study of coronary CT angiography for the patients with coronary artery stenting
Acronym
Prognostic study of coronary CT angiography for the patients with coronary artery stenting
Scientific Title
Prognostic study of coronary CT angiography for the patients with coronary artery stenting
Scientific Title:Acronym
Prognostic study of coronary CT angiography for the patients with coronary artery stenting
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To perform coronary CT for the patients after coronary stenting and subsequent prognostic observation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Death (cardiac or non cardiac)
Non fatal acute coronary syndrome
Late coronary revascularization (after six months of CT examination)
Key secondary outcomes
early coronary revascularization (within six months of CT examination)
recurrence of chest symptoms
re-evaluation of coronary arteries
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 requiring assessment of stenosis grade of in-stent or out-of-stent lesions
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
400
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
Nothing
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 | 07 | Month | 30 | 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
No longer recruiting
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
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Purpose: To perform coronary CT for the patients after coronary stenting and subsequent prognostic observation.
Observational Study:
Death (cardiac or non cardiac)
Non fatal acute coronary syndrome
Late coronary revascularization (after six months of CT examination)
Management information
Registered date
| 2023 | Year | 07 | Month | 30 | Day |
Last modified on
| 2025 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057753
