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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042459
Receipt No. R000048354
Scientific Title Tokyo / Kanagawa / Chiba / Shizuoka / Ibaraki active OCT applications for ACS regarding patient background (TACTICS background registry)
Date of disclosure of the study information 2020/11/16
Last modified on 2020/11/15

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Basic information
Public title Tokyo / Kanagawa / Chiba / Shizuoka / Ibaraki active OCT applications for ACS regarding patient background (TACTICS background registry)
Acronym TACTICS background registry
Scientific Title Tokyo / Kanagawa / Chiba / Shizuoka / Ibaraki active OCT applications for ACS regarding patient background (TACTICS background registry)
Scientific Title:Acronym TACTICS background registry
Region
Japan

Condition
Condition Acute Coronary Syndrome (ACS)
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess baseline characteristics of patients with acute coronary syndrome (ACS) who were clinically chosen the revascularization strategy without Optical coherence tomography (OCT).
Basic objectives2 Others
Basic objectives -Others By examining the difference between the background of ACS evaluated by OCT and the overall ACS patients in Japan, we may obtain the data to overcome the limitation of selection bias and show the importance of OCT-guided PCI in ACS patients.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes To assess the difference of the clinical and procedural characteristics between the patient cohorts enrolled and not-enrolled to the TACTICS registry.
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

Not applicable
Gender Male and Female
Key inclusion criteria a) ACS patients who underwent PCI within 24 hours.
b) Patients who are not enrolled to the TACTICS registry.
c) Patients aged 20 year or older.
Key exclusion criteria Patients who do not agree with the opt-out details. (Informed consent was obtained in the form of opt-out on the web-site/posting in the hospital.)
Target sample size 2200

Research contact person
Name of lead principal investigator
1st name Toshiro
Middle name
Last name shinke
Organization Showa University
Division name Division of Cardiology
Zip code 142-8666
Address 1-5-8, Hatanodai Shinagawa-ku, Tokyo, Japan
TEL 03-3784-8539
Email shinke@med.showa-u.ac.jp

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

Sponsor
Institute Showa University Division of Cardiology
Institute
Department

Funding Source
Organization Abbott Medical Japan LLC.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Showa University Certified Review Board
Address 1-5-8, Hatanodai Shinagawa-ku, Tokyo, 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 昭和大学病院(東京都)、昭和大学藤が丘病院(神奈川県)、昭和大学横浜市北部病院(神奈川県)、昭和大学江東豊洲病院(東京都)、江戸川病院(東京都)、NTT東日本関東病院(東京都)、亀田総合病院(千葉県)、関東労災病院(神奈川県)、菊名記念病院(神奈川県)、榊原記念病院(東京都)、順天堂大学病院(東京都)、順天堂大学静岡病院(静岡県)、新東京病院(千葉県)、聖マリアンナ医科大学(神奈川県)、帝京大学医学部附属病院(東京都)、東海大学医学部付属病院(神奈川県)、東京医科歯科大学(東京都)、東京医科大学病院(東京都)、東京女子医科大学(東京都)、東京大学医学部附属病院(東京都)、日本医大千葉北総病院、ひたち医療センター(茨城県)、武蔵野赤十字病院(東京都)、横浜栄共済病院(神奈川県)、横浜市立大学病院付属市民病院医療センター(神奈川県)、横浜南共済病院(神奈川県)、綾瀬循環器病院(東京都)、土浦協同病院(茨城県)

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 16 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 Open public recruiting
Date of protocol fixation
2019 Year 11 Month 13 Day
Date of IRB
2020 Year 10 Month 05 Day
Anticipated trial start date
2019 Year 11 Month 13 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 To assess baseline characteristics of patients with acute coronary syndrome (ACS) who were clinically chosen the revascularization strategy without Optical coherence tomography (OCT).
By examining the difference between the background of ACS evaluated by OCT and the overall ACS patients in Japan, we may obtain the data to overcome the limitation of selection bias and show the importance of OCT-guided PCI in ACS patients.

Management information
Registered date
2020 Year 11 Month 15 Day
Last modified on
2020 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048354

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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