UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040860
Receipt number R000046654
Scientific Title Comparison of Early Vascular Response to 2nd-generetion Drug-Eluting Stents Between ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction
Date of disclosure of the study information 2020/08/01
Last modified on 2020/06/24 19:54:49

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Basic information

Public title

Comparison of Early Vascular Response to 2nd-generetion Drug-Eluting Stents Between ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction

Acronym

Comparison of Early Vascular Response to 2nd-generetion Drug-Eluting Stents Between ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction

Scientific Title

Comparison of Early Vascular Response to 2nd-generetion Drug-Eluting Stents Between ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction

Scientific Title:Acronym

Comparison of Early Vascular Response to 2nd-generetion Drug-Eluting Stents Between ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction

Region

Japan


Condition

Condition

Acute Myocardial Infarction

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare difference of early vascular response to stents between STEMI and NSTEMI

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

strut coverage at 3-month

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

stent implantation

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


Not applicable

Gender

Male and Female

Key inclusion criteria

patients received stent implantation for AMI

Key exclusion criteria

patients with previous PCI or CABG

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Masaharu
Middle name
Last name Ishihara

Organization

Hyogo College of Medicine

Division name

cardiovascular and renal disease medicine

Zip code

663-8131

Address

1-1, Mukogawacho, Nishinomiya, Hyogo

TEL

0798-45-6553

Email

hpxkg043@ybb.ne.jp


Public contact

Name of contact person

1st name Kojiro
Middle name
Last name Miki

Organization

Hyogo College of Medicine

Division name

cardiovascular and renal disease medicine

Zip code

663-8131

Address

1-1, Mukogawacho, Nishinomiya, Hyogo

TEL

0798-45-6553

Homepage URL


Email

hpxkg043@ybb.ne.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

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, Mukogawacho, Nishinomiya, Hyogo

Tel

0798-45-6066

Email

rinri@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

2020 Year 08 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


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

Preinitiation

Date of protocol fixation

2020 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2020 Year 08 Month 01 Day

Last follow-up date

2024 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 06 Month 22 Day

Last modified on

2020 Year 06 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046654


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name