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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name