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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038372
Receipt No. 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 2019/10/23

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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 168

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
Email 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
Email appleorangeeleven@gmail.com

Sponsor
Institute Hyogo College of Medicine
Institute
Department

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
Email 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
2019 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043403

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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