UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038372 |
|---|---|
| Receipt number | R000043403 |
| Scientific Title | Comparison of Severity in Non-Culprit Lesion Between STEMI and NSTEMI: De novo study of Non-Culprit SYNTAX score and Non-Culprit Gensini Score |
| Date of disclosure of the study information | 2019/12/01 |
| Last modified on | 2020/08/29 10:53:49 |
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Basic information
Public title
Comparison of Severity in Non-Culprit Lesion Between STEMI and NSTEMI: De novo study of Non-Culprit SYNTAX score and Non-Culprit Gensini Score
Acronym
Comparison of Severity in Non-Culprit Lesion Between STEMI and NSTEMI: De novo study of Non-Culprit SYNTAX score and Non-Culprit Gensini Score
Scientific Title
Comparison of Severity in Non-Culprit Lesion Between STEMI and NSTEMI: De novo study of Non-Culprit SYNTAX score and Non-Culprit Gensini Score
Scientific Title:Acronym
Comparison of Severity in Non-Culprit Lesion Between STEMI and NSTEMI: De novo study of Non-Culprit SYNTAX score and Non-Culprit Gensini Score
Region
| Japan |
Condition
Condition
Acute Myocardial Infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the severity of non-culprit lesion between STEMI and NSTEMI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the extent of non-culprit lesion of coronary artery in coronary angiogram findings between STEMI and NSTEMI diagnosed by the new universal definition
Key secondary outcomes
Impact of Extent of Non-Culprit Lesions on One-Year Outcomes in Patients with Acute Myocardial Infarction
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patient with AMI underwent PCI
Key exclusion criteria
case of prior CABG
Target sample size
249
Research contact person
Name of lead principal investigator
| 1st name | Tanaka |
| Middle name | |
| Last name | Takamasa |
Organization
Hyogo College of Medicine
Division name
Department of Cardiovascular and Renal Medicine
Zip code
663-8501
Address
1-1 Mukogawatyou Nishinomiyashi Hyogoken
TEL
0798456111
appleorangeeleven@gmail.com
Public contact
Name of contact person
| 1st name | Tanaka |
| Middle name | |
| Last name | Takamasa |
Organization
Hyogo College of Medicine
Division name
Department of Cardiovascular and Renal Medicine
Zip code
663-8501
Address
1-1 Mukogawatyou Nishinomiyashi Hyogoken
TEL
0798456111
Homepage URL
appleorangeeleven@gmail.com
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 Mukogawatyou Nishinomiyashi Hyogoken
Tel
0798456111
appleorangeeleven@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 | 12 | 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
168
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
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study consisted of consecutive 168 patients who underwent primary percutaneous coronary intervention (PCI) for MI between 2015 and 2017. We compared the severity of CAD between STEMI and NSTEMI, using with the non-culprit -SYNTAX score and non-culprit -Gensini score.
Management information
Registered date
| 2019 | Year | 10 | Month | 23 | Day |
Last modified on
| 2020 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043403
