UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037332 |
|---|---|
| Receipt number | R000042551 |
| Scientific Title | Cohort Study of Left Main Coronary Intervention in Japanese National Hospital Organization Group |
| Date of disclosure of the study information | 2019/07/12 |
| Last modified on | 2024/01/15 15:13:29 |
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Basic information
Public title
Cohort Study of Left Main Coronary Intervention in Japanese National Hospital Organization Group
Acronym
LM-JANHO
Scientific Title
Cohort Study of Left Main Coronary Intervention in Japanese National Hospital Organization Group
Scientific Title:Acronym
LM-JANHO
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to investigate clinical outcome of percutaneous coronary intervention (PCI) at the left main (LM) coronary artery in a large scale of cohort of National Hospital Organization (NHO), Japan, where imaging-guided intervention has been almost completely performed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Major adverse cerebro- and cardio-vascular events (MACCE) defined as composite endpoints of all cause of death, cerebrovascular disorder, myocardial infarction and clinical driven revascularization at 3-year follow-up after the LM PCI
Key secondary outcomes
Cumulative occurrence of MACCE and each event at discharge, 1-year, 2-year and 3-year follow-up
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
1) more than 20 years old
2) suitable lesion for drug-eluting stent implantation in the LM
3) de novo lesion
4) tolerable for dual antiplatelet therapy for more than 6 months
5) LMPCI performed in the NHO group from January 1, 2016 to December 31, 2020
Key exclusion criteria
1) In-stent restenotic lesion
2) Chronic total occlusion
3) Left anterior descending artery and/or circumflex artery are protected by prior coronary bypass surgery
4) Female with possible or definite pregnancy
5) Unsuitable candidate judged by the responsible doctor
6) Rejection for the recruitment of personal information to the study after the notice of the study information according to the opt-out system
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Murasato |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Department of Cardiology
Zip code
810-8563
Address
1-8-1, Jigyohama, Chuo, Fukuoka, Japan
TEL
092-852-0700
y.murasato@gmail.com
Public contact
Name of contact person
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Murasato |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Department of Cardiology
Zip code
810-8563
Address
1-8-1, Jigyohama, Chuo, Fukuoka, Japan
TEL
0928520700
Homepage URL
y.murasato@gmail.com
Sponsor or person
Institute
Department of Cardiology, National Hospital Organization Kyushu Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyushu Medical Center
Address
1-8-1, Jigyohama, Chuo, Fukuoka, Japan
Tel
0928520700
y.murasato@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 12 | 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
1000
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
| 2018 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 06 | Month | 30 | Day |
Other
Other related information
The enrollment is started after the notice of study information in the home pages of participating NHO hospitals according to the opt out system. For the enrolled subjects, 3 follow up data, at 1 year, 2 year and 3 year will be obtained from medical record or telephone interview.
Management information
Registered date
| 2019 | Year | 07 | Month | 11 | Day |
Last modified on
| 2024 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042551
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
