UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051548 |
|---|---|
| Receipt number | R000058818 |
| Scientific Title | Treatment selection of diffuse coronary artery disease: Systematic review and meta-analysis |
| Date of disclosure of the study information | 2023/07/07 |
| Last modified on | 2024/02/27 12:58:57 |
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Basic information
Public title
Treatment selection of diffuse coronary artery disease: Systematic review and meta-analysis
Acronym
Treatment selection of diffuse coronary artery disease: Systematic review and meta-analysis
Scientific Title
Treatment selection of diffuse coronary artery disease: Systematic review and meta-analysis
Scientific Title:Acronym
reatment selection of diffuse coronary artery disease: Systematic review and meta-analysis
Region
| Japan |
Condition
Condition
coronary artery diffuse disease
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Invasive treatments for diffuse coronary artery lesions are roughly divided into percutaneous coronary angioplasty (PCI) and surgery, but the relationship between treatment choice and prognosis has not been clarified.
Therefore, in this study, we will comprehensively examine the existing studies on PCI or surgery for diffuse lesions, and clarify the relationship between treatment selection and prognosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The hazard ratio for 1-year survival or 1-year mortality
Key secondary outcomes
the hazard ratio for 5-year survival or 5-year mortality, retreatment rate, Myocardial infarction incidence, Stroke incidence, treatment success rate
Base
Study type
Others,meta-analysis etc
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) a clear definition of coronary artery disease
2) studies for diffuse coronary artery-diseased patients who were treated with percutaneous coronary intervention or cardiac surgery
3) Hazard rate of 1-year survival or 1-year mortality, 5-year survival rate or 5-year mortality, MACCE
Key exclusion criteria
1) non-English articles, series of < 10 patients, case reports, animal studies, abstracts, editorials, commentaries, systematic reviews, and narrative reviews
2) pediatric, infection, drug treatment, cell treatment, other artery diseases, chronic total occlusion (CTO), graft disease, in-stent restenosis (ISR), diagnosis, treatment technique,
bare metal stent (BMS)
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Ikehara |
Organization
Joint Graduate School of Tokyo Womens Medical University and Waseda University
Division name
Cooperative Major in Advanced Biomedical Sciences
Zip code
162-0056
Address
2-2 Wakamatsucho, Shinjuku, Tokyo, Japan
TEL
+81-03-5369-7300
mikehara@akane.waseda.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Ikehara |
Organization
Joint Graduate School of Tokyo Womens Medical University and Waseda University
Division name
Cooperative Major in Advanced Biomedical Sciences
Zip code
162-0056
Address
2-2 Wakamatsucho, Shinjuku, Tokyo, Japan
TEL
+81-03-5369-7300
Homepage URL
mikehara@akane.waseda.jp
Sponsor or person
Institute
Waseda university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
none
Address
none
Tel
0
none@.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
| 2023 | Year | 07 | Month | 07 | 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
0
Results
Results date posted
| 2024 | Year | 02 | Month | 27 | Day |
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Search engines including PubMed, Embase, Web of Science, and Cochrane Library, and reported using the preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA) checklist guidelines.
Search terms: coronary artery AND diffuse AND (PCI OR percutaneous coronary intervention OR CABG OR coronary artery bypass grafting OR PTCA OR percutaneous transluminal coronary angioplasty OR endarterectomy OR atherectomy OR stent OR graft OR DCB OR drug coating balloon)
Management information
Registered date
| 2023 | Year | 07 | Month | 07 | Day |
Last modified on
| 2024 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058818
| 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 |
