UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044299
Receipt number R000037331
Scientific Title Comparison of plaque in non-culprit vessels with STEMI and STEMI
Date of disclosure of the study information 2021/05/25
Last modified on 2021/05/23 17:57:30

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Basic information

Public title

Comparison of plaque in non-culprit vessels with STEMI and STEMI

Acronym

Comparison of plaque in non-culprit vessels with STEMI and STEMI

Scientific Title

Comparison of plaque in non-culprit vessels with STEMI and STEMI

Scientific Title:Acronym

Comparison of plaque in non-culprit vessels with STEMI and STEMI

Region

Japan


Condition

Condition

Acute myocardial Infarction

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of plaque in non-culprit vessels with NSTEMI and STEMI in patients undergoing primary PCI.

Basic objectives2

Others

Basic objectives -Others

Evaluation of plaque

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Prevalence of Thin Cap Fibroathroma in non-culprit vessels with STEMI and NSTEMI

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

30 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

denovo ACS cases

Key exclusion criteria

Culprit vessel at LMT
PCI was performed to two vessels
prior CABG cases
Allergy of contrast medium
Chronic kidney disease cases
Disobedience of dosing compliance

Target sample size

48


Research contact person

Name of lead principal investigator

1st name Masaharu
Middle name
Last name Ishihara

Organization

Hyogo College of Medicine

Division name

Cardiovascular

Zip code

6638501

Address

1-1 mukogawa, nishinomiya, hyogo

TEL

0798-45-6111

Email

ma-isihara@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

Cardiovascular

Zip code

6638501

Address

1-1 mukogawa, nishinomiya, hyogo

TEL

0798-45-6111

Homepage URL


Email

ta-tanaka@hyo-med.ac.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

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 mukogawa, nishinomiya, hyogo

Tel

0798-45-6111

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 05 Month 25 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

231

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

2019 Year 08 Month 18 Day

Date of IRB

2019 Year 10 Month 18 Day

Anticipated trial start date

2019 Year 11 Month 01 Day

Last follow-up date

2020 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

retrospective study


Management information

Registered date

2021 Year 05 Month 23 Day

Last modified on

2021 Year 05 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037331


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name