UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049237 |
|---|---|
| Receipt number | R000056077 |
| Scientific Title | Deep Learning-Based Prediction of Cardiovascular Outcomes using Optical Coherence Tomography in Patients with Acute Coronary Syndrome |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2022/10/17 12:50:03 |
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Basic information
Public title
Deep Learning-Based Prediction of Cardiovascular Outcomes using Optical Coherence Tomography in Patients with Acute Coronary Syndrome
Acronym
Deep Learning-Based Prediction of Cardiovascular Outcomes using Optical Coherence Tomography in Patients with Acute Coronary Syndrome
Scientific Title
Deep Learning-Based Prediction of Cardiovascular Outcomes using Optical Coherence Tomography in Patients with Acute Coronary Syndrome
Scientific Title:Acronym
Deep Learning-Based Prediction of Cardiovascular Outcomes using Optical Coherence Tomography in Patients with Acute Coronary Syndrome
Region
| Japan |
Condition
Condition
acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To create a prognosis prediction model directly from post-percutaneous coronary syndrome (PCI) optical coherence tomography (OCT) images of patients with acute coronary syndrome using a deep learning model.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Target vessel failure
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients enrolled in a previous study, "A retrospective multicenter registry of the morphological characteristics of responsible plaques in patients with acute coronary syndromes from the perspective of age and gender" (UMIN000038442).
(ii) Patients who received OCT examination after PCI to ACS
Key exclusion criteria
(1) Patients who have asked not to participate in this study based on publicly available information.
(2) Patients who had ACS due to in-stent restenosis or occlusion
(3) Patients with graft vessels
(4) Patients with lesions in the left main trunk or the ostium of the right coronary artery
(5) Patients who did not undergo stenting at PCI
(6) Patients with Thrombolysis in myocardial infarction trial (TIMI) flow grade 2 or less at the final coronary angiogram
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Otake |
Organization
Kobe University Hospital
Division name
Division of Cardiovascular Medicine
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
0783825846
hotake@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyo |
| Middle name | |
| Last name | Hamana |
Organization
Kobe University Hospital
Division name
Division of Cardiovascular Medicine
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
0783825846
Homepage URL
tomohamachi@yahoo.co.jp
Sponsor or person
Institute
Kobe University, department of cardiology
Institute
Department
Personal name
Funding Source
Organization
Kobe 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
Kobe university hospital clinical and translational research center
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
Tel
0783825846
kansatsu@med.kobe-u.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 | 01 | 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
| 2022 | Year | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | 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
None
Management information
Registered date
| 2022 | Year | 10 | Month | 17 | Day |
Last modified on
| 2022 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056077
