UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050045 |
|---|---|
| Receipt number | R000057010 |
| Scientific Title | Revascularization strategy for coronary artery disease -left main trunk- |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2023/07/16 14:28:50 |
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Basic information
Public title
Revascularization strategy for coronary artery disease -left main trunk-
Acronym
RELIANCE LMT
Scientific Title
Revascularization strategy for coronary artery disease -left main trunk-
Scientific Title:Acronym
RELIANCE LMT
Region
| Japan |
Condition
Condition
De novo left main (LM)and LM bifurcation lesions treated with percutaneous coronary intervention (PCI) or coronary artery bypass graft(CABG).
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess clinical long-term outcome of PCI and CABG in daily practice
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
All cause death
Key secondary outcomes
30days, 1year, 2years, and 5years
Procedure complication
Cardiac death
Acute myocardial infarction(AMI)
Ischemic stroke
Hemorrhagic stroke
Stent thrombosis
Bypass graft failure
Target lesion revascularization (TLR)
Target vessel revascularization (TVR)
Non-TVR
Bleeding complication
Hospitalization of heart failure
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) Patients undergoing PCI or CABG for denovo LMT, LMT bifurcation, ostial left anterior descending artery (LAD) or left circumflex artery (LCX)
1. Ostial LMT, LMT body
2. LMT bifurcation lesions, Medina(1,1,1), (1,0,1) , (1,0,0),(1,1,0)
3. ostial LAD(0,1,0), Ostial LCX (0.0.1), ostial LAD and LCX(0,1,1)
4. patients from 1 to 3 with multivessel disease
TLR is registered for cohort-2 (RELIANCE LMT ISR)
ST elevated MI (STEMI) with the culprit of LMT are registered in cohort-3 (RELIANCE LMT ACS)
(2) PCI and CABG between 2012 and 2026.
(3) 18 years old or more
Key exclusion criteria
(1) History of PCI for LMT
(2) History of PCI for ostial (<5mm) LAD or ostial LCX
(3) CABG history
(4) Valve heart disease (VHD), aortic disease, myocardial disease intervened by percutaneous or cardiac surgery
(5) Concomitant CABG with VHD, aortic, or myocardial disease
(6) STEMI except for LMT
(7) Shock vital at admission except for STEMI of LMT
(8) Other patients judged for inappropriate for registry by institute principal investigator.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Yamawaki |
Organization
Saiseikai Yokohama City Eastern Hospital
Division name
Department of cardiology
Zip code
230-8765
Address
Tsurumiku Shimosueyoshi 3-6-1, 230-8765, Yokohama, Japan
TEL
+81-45-576-3000
m_yamawaki@tobu.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Yamawaki |
Organization
Saiseikai Yokohama City Eastern Hospital
Division name
Department of cardiology
Zip code
230-8765
Address
Tsurumiku Shimosueyoshi 3-6-1, 230-8765, Yokohama, Japan
TEL
+81-45-576-3000
Homepage URL
m_yamawaki@tobu.saiseikai.or.jp
Sponsor or person
Institute
Saiseikai Yokohama City Eastern Hospital
Institute
Department
Personal name
Funding Source
Organization
Medtronic Japan Co.,Ltd
TERUMO Co.,Ltd
The Japan Research Foundation for Healthy Aging
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Yokohama City Eastern Hospital
Address
Tsurumiku Tsukunocho 23-13-604
Tel
+81-45-576-3000
k_harita@tobu.saiseikai.or.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
足利赤十字病院（栃木県）
大阪府済生会中津病院（大阪府）
昭和大学（東京都）
榊原記念病院（東京都）
早稲田大学 先端生命医科学センター（TWIns）（東京都）
九州医療センター（福岡県）
札幌心臓血管クリニック（北海道）
湘南鎌倉総合病院（神奈川県）
豊橋ハートセンター（愛知県）
国立循環器病センター（大阪府）
福岡和白病院（福岡県）
宮崎市郡医師会病院（宮崎県）
武蔵野日赤病院（東京都）
山口大学医学部付属病院（山口県）
北播磨医療センター（兵庫県）
川崎医科大学付属病院（岡山県）
済生会横浜市東部病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 01 | 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
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective and prospective observational registry
Management information
Registered date
| 2023 | Year | 01 | Month | 15 | Day |
Last modified on
| 2023 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057010
| 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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