UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048590 |
|---|---|
| Receipt number | 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 | 2023/08/07 11:24:28 |
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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
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
tactics@ofc.showa-u.ac.jp
Sponsor or person
Institute
Division of Cardiology, Department of Medicine, Showa University School of Medicine
Institute
Department
Personal name
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
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
No longer recruiting
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 | 20 | 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
| 2023 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054790
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