UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044299 |
|---|---|
| Receipt number | R000037331 |
| Scientific Title | Comparison of plaque in non-culprit vessels with STEMI and STEMI |
| Date of disclosure of the study information | 2021/05/25 |
| Last modified on | 2021/05/23 17:57:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of plaque in non-culprit vessels with STEMI and STEMI
Acronym
Comparison of plaque in non-culprit vessels with STEMI and STEMI
Scientific Title
Comparison of plaque in non-culprit vessels with STEMI and STEMI
Scientific Title:Acronym
Comparison of plaque in non-culprit vessels with STEMI and STEMI
Region
| Japan |
Condition
Condition
Acute myocardial Infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of plaque in non-culprit vessels with NSTEMI and STEMI in patients undergoing primary PCI.
Basic objectives2
Others
Basic objectives -Others
Evaluation of plaque
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of Thin Cap Fibroathroma in non-culprit vessels with STEMI and NSTEMI
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
| 30 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
denovo ACS cases
Key exclusion criteria
Culprit vessel at LMT
PCI was performed to two vessels
prior CABG cases
Allergy of contrast medium
Chronic kidney disease cases
Disobedience of dosing compliance
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Masaharu |
| Middle name | |
| Last name | Ishihara |
Organization
Hyogo College of Medicine
Division name
Cardiovascular
Zip code
6638501
Address
1-1 mukogawa, nishinomiya, hyogo
TEL
0798-45-6111
ma-isihara@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Tanaka |
Organization
Hyogo College of Medicine
Division name
Cardiovascular
Zip code
6638501
Address
1-1 mukogawa, nishinomiya, hyogo
TEL
0798-45-6111
Homepage URL
ta-tanaka@hyo-med.ac.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
Self funding
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 mukogawa, nishinomiya, hyogo
Tel
0798-45-6111
ta-tanaka@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
| 2021 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
231
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
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2021 | Year | 05 | Month | 23 | Day |
Last modified on
| 2021 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037331
