UMIN-CTR Clinical Trial

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
Email	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
Email	tomohamachi@yahoo.co.jp

Sponsor
Institute	Kobe University, department of cardiology
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056077