UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040860 |
|---|---|
| Receipt number | R000046654 |
| Scientific Title | Comparison of Early Vascular Response to 2nd-generetion Drug-Eluting Stents Between ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2020/06/24 19:54:49 |
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Basic information
Public title
Comparison of Early Vascular Response to 2nd-generetion Drug-Eluting Stents Between ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction
Acronym
Comparison of Early Vascular Response to 2nd-generetion Drug-Eluting Stents Between ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction
Scientific Title
Comparison of Early Vascular Response to 2nd-generetion Drug-Eluting Stents Between ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction
Scientific Title:Acronym
Comparison of Early Vascular Response to 2nd-generetion Drug-Eluting Stents Between ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction
Region
| Japan |
Condition
Condition
Acute Myocardial Infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare difference of early vascular response to stents between STEMI and NSTEMI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
strut coverage at 3-month
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
stent implantation
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
patients received stent implantation for AMI
Key exclusion criteria
patients with previous PCI or CABG
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masaharu |
| Middle name | |
| Last name | Ishihara |
Organization
Hyogo College of Medicine
Division name
cardiovascular and renal disease medicine
Zip code
663-8131
Address
1-1, Mukogawacho, Nishinomiya, Hyogo
TEL
0798-45-6553
hpxkg043@ybb.ne.jp
Public contact
Name of contact person
| 1st name | Kojiro |
| Middle name | |
| Last name | Miki |
Organization
Hyogo College of Medicine
Division name
cardiovascular and renal disease medicine
Zip code
663-8131
Address
1-1, Mukogawacho, Nishinomiya, Hyogo
TEL
0798-45-6553
Homepage URL
hpxkg043@ybb.ne.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
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
Hyogo College of Medicine
Address
1-1, Mukogawacho, Nishinomiya, Hyogo
Tel
0798-45-6066
rinri@hyo-med.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 22 | Day |
Last modified on
| 2020 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046654
