UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of Vascular Healing Response after Stent Implantation between Non-ST-Elevation Myocardial Infarction and ST-Elevation Myocardial Infarction: A Follow-up Optical Coherence Tomography Study
Acronym	Stent Healing Response of Acute Myocardial Infarction
Scientific Title	Comparison of Vascular Healing Response after Stent Implantation between Non-ST-Elevation Myocardial Infarction and ST-Elevation Myocardial Infarction: A Follow-up Optical Coherence Tomography Study
Scientific Title:Acronym	Stent Healing Response of Acute Myocardial Infarction
Region	Japan

Condition
Condition	Acute myocardial infarcion
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It has been revealed that patients with non-ST-elevation myocardial infarction (NSTEMI) have worse long-term prognosis than those with ST-elevation MI (STEMI). Degree of neointimal stent struts coverage is associated with the risk of stent thrombosis. This poor prognosis in patients with NSTEMI may be attributable to arterial healing response after stent deployment at the culprit lesion.We evaluated the difference of healing response after drug-eluting stents implantation between patients with NSTEMI and STEMI.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate the rate of the uncovered struts in patient with NSTEMI and STEMI at the one-year follow-up.
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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	From May 2015 to Nov 2020, patients who underwent a one-year follow-up OFDI examination at Hyogo College of Medicine (Hyogo, Japan) will be reviewed.
Key exclusion criteria	OFDI pullbacks impaired imaging quality were not analyzable
Target sample size	54

Research contact person
Name of lead principal investigator	1st name Masaharu Middle name Last name Ishihara
Organization	Hyogo College of Medicine
Division name	Department of cardiovascular and renal medicine
Zip code	6638501
Address	1-1 Mukogawa Nishinomiya Hyogo, Japan
TEL	0798456553
Email	ma-ishihara@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	Department of cardiovascular and renal medicine
Zip code	6638501
Address	1-1 Mukogawa Nishinomiya Hyogo, Japan
TEL	0798456553
Homepage URL
Email	ta-tanaka@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

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 Mukogawa Nishinomiya Hyogo, Japan
Tel	0798456553
Email	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 09 Month 04 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	54
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	No longer recruiting
Date of protocol fixation	2020 Year 10 Month 25 Day
Date of IRB	2020 Year 11 Month 25 Day
Anticipated trial start date	2021 Year 01 Month 01 Day
Last follow-up date	2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	m

Management information
Registered date	2021 Year 09 Month 02 Day
Last modified on	2022 Year 03 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050602