UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053600 |
|---|---|
| Receipt number | R000051456 |
| Scientific Title | Comparison of artificial intelligence automated quantification and human visual assessment of calcification and vessel sizing in in-vivo optical coherence tomography images |
| Date of disclosure of the study information | 2024/02/13 |
| Last modified on | 2024/08/19 12:47:06 |
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Basic information
Public title
Comparison of artificial intelligence automated quantification and human visual assessment of calcification and vessel sizing in in-vivo optical coherence tomography images
Acronym
CONTEST study
Scientific Title
Comparison of artificial intelligence automated quantification and human visual assessment of calcification and vessel sizing in in-vivo optical coherence tomography images
Scientific Title:Acronym
CONTEST study
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to compare artificial intelligence automated quantification and human visual assessment of calcified lesion and vessel sizing in in-vivo optical coherence tomography (OCT).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in artificial intelligence and human visual assessment of calcified plaque and vessel size in pre-OCT images
Key secondary outcomes
Comparison of strategies based on artificial intelligence and human visual assessment
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) All patients should be over 18 years of age.
2) Patients with coronary artery disease must have a clinical indication for percutaneous coronary intervention.
3) Patients treated with OCT-guided PCI.
Key exclusion criteria
1)Ostial left main artery or ostial right coronary artery lesions.
2)Poor pre-OCT images.
3)Lesions which OCT does not cross.
4)Female patients of childbearing potential.
5)Life expectancy less than 12 months.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naotaka |
| Middle name | |
| Last name | Okamoto |
Organization
Osaka Rosai Hospital
Division name
Cardiology
Zip code
5918025
Address
1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, Japan
TEL
072-252-3561
okamo10nao@osakah.johas.go.jp
Public contact
Name of contact person
| 1st name | Naotaka |
| Middle name | |
| Last name | Okamoto |
Organization
Osaka Rosai Hospital
Division name
Cardiology
Zip code
5918025
Address
1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, Japan
TEL
072-252-3561
Homepage URL
okamo10nao@osakah.johas.go.jp
Sponsor or person
Institute
Osaka Rosai Hospital
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
Osaka Rosai Hospital
Address
1179-3 Nagasone-cho, Kita-ku, Sakai, Osaka, Japan
Tel
072-252-3561
soumukatyou@osakah.johas.go.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
| 2024 | Year | 02 | Month | 13 | 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
| Delay expected |
Results Delay Reason
Delay of data analysis
Date of the first journal publication of results
| 2024 | Year | 03 | Month | 10 | Day |
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
| 2021 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None.
Management information
Registered date
| 2024 | Year | 02 | Month | 12 | Day |
Last modified on
| 2024 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051456
