UMIN-CTR Clinical Trial

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
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	2020 Year 08 Month 29 Day

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