UMIN-CTR Clinical Trial

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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048590
Receipt No. R000054790
Scientific Title ST-elevation acute myocardial infarction and clinical outcomes treated by optical coherence tomography-guided percutaneous coronary intervention (ATLAS-OCT Study)
Date of disclosure of the study information 2022/08/04
Last modified on 2022/08/04

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Basic information
Public title ST-elevation acute myocardial infarction and clinical outcomes treated by optical coherence tomography-guided percutaneous coronary intervention (ATLAS-OCT Study)
Acronym ATLAS-OCT Study
Scientific Title ST-elevation acute myocardial infarction and clinical outcomes treated by optical coherence tomography-guided percutaneous coronary intervention (ATLAS-OCT Study)
Scientific Title:Acronym ATLAS-OCT Study
Region
Japan

Condition
Condition ST-elevation acute myocardial infarction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to determine the achievement rate of optical coherence tomography (OCT)-guided primary percutaneous coronary intervention (PCI) in patients with ST-elevation acute myocardial infarction who are indicated for primary percutaneous coronary intervention.
Basic objectives2 Others
Basic objectives -Others The incidence rate of major adverse cardiovascular events (all-cause death, myocardial infarction or target vessel revascularization) at 1 year
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The achievement rate of OCT-guided primary PCI in patients with ST-elevation acute myocardial infarction who are indicated for primary percutaneous coronary intervention.
Key secondary outcomes 1 One-year rate of major adverse cardiovascular events (all-cause death, myocardial infarction or target vessel revascularization)
2 One-year rate of target vessel revascularization
3 The achievement rate of each step of OCT-guided primary PCI (assessment of etiology, stent sizing and stent optimization)
4 Stent expansion
5 Post-procedural OCT findings (edge dissection, reference lumen narrowing, malapposition, in-stent minimum lumen area, stent expansion, minimum stent area, intrastent plaque or thrombus protrusion)
6 Comparison of post-procedural OCT findings between patients assessed by Ultreon system and AptiVue system
7 Comparison of procedural characteristics between patients assessed by Ultreon system and AptiVue system
8 Comparison of clinical outcomes between patients assessed by Ultreon system and AptiVue system

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 STEMI patient presenting within 24 hours of symptom onset and undergoing primary PCI
2 Willing and able to provide written informed consent
3 18 years old and more
Key exclusion criteria 1 Patient participating in any other research that contradicts the result of this study
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Toshiro
Middle name
Last name Shinke
Organization Showa University School of Medicine
Division name Division of Cardiology, Department of Medicine
Zip code 142-8666
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL 03-3784-8000
Email shinke@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Myong Hwa
Middle name
Last name Yamamoto
Organization Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics
Division name ATLAS-OCTStudy Secretariat
Zip code 157-8577
Address 6-11-11, Kitakarasuyama, Setagaya-ku, Tokyo
TEL 03-3300-5247
Homepage URL
Email tactics@ofc.showa-u.ac.jp

Sponsor
Institute Division of Cardiology, Department of Medicine, Showa University School of Medicine
Institute
Department

Funding Source
Organization Abbott Medical Japan LLC. (Minato-ku, Tokyo, Japan)
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Showa University Research Ethics Review Board
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
Tel 03-3784-8129
Email m-rinri@ofc.showa-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 代表研究責任医師
 昭和大学医学部内科学講座循環器内科学部門 教授 新家 俊郎
共同代表研究責任医師
 東京医科歯科大学 医学部附属病院 循環器内科 特任准教授 米津 太志
 昭和大学江東豊洲病院 循環器センター 循環器内科 准教授 若林 公平
試験実施施設
 大阪府済生会中津病院(大阪府)
 川崎医科大学附属病院(岡山県)  
 川崎市立多摩病院 (神奈川県)
 北里大学病院(神奈川県)
 岐阜大学医学部附属病院(岐阜県)
 順天堂大学医学部附属静岡病院(静岡県) 
 湘南鎌倉総合病院(神奈川県) 
 昭和大学江東豊洲病院(東京都)
 昭和大学病院(東京都)
 昭和大学横浜市北部病院(神奈川県)
 新東京病院(千葉県)
 土浦協同病院(茨城県)
 東京医科歯科大学医学部附属病院(東京都)     
 日本医科大学千葉北総病院(千葉県)
 兵庫県立淡路医療センター(兵庫県)
 横浜南共済病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2022 Year 08 Month 04 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 06 Month 22 Day
Date of IRB
2022 Year 07 Month 28 Day
Anticipated trial start date
2022 Year 08 Month 08 Day
Last follow-up date
2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Investigator-initiated prospective multicenter observational study

Management information
Registered date
2022 Year 08 Month 04 Day
Last modified on
2022 Year 08 Month 04 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054790

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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