UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042459 |
|---|---|
| Receipt number | 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 | 2022/11/21 13:37:43 |
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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
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
tactics@ofc.showa-u.ac.jp
Sponsor or person
Institute
Showa University Division of Cardiology
Institute
Department
Personal name
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
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)、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
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 31 | Day |
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
| 2022 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048354
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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