UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039797
Receipt number R000045378
Scientific Title Acute and Chronic Outcomes of Acute Coronary Syndrome Patients Treated with Percutaneous Coronary Intervention: A Multi-center Study in Aomori
Date of disclosure of the study information 2020/04/01
Last modified on 2022/03/14 12:53:08

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Basic information

Public title

Acute and Chronic Outcomes of Acute Coronary Syndrome Patients Treated with Percutaneous Coronary Intervention: A Multi-center Study in Aomori

Acronym

Aomori ACS Registry

Scientific Title

Acute and Chronic Outcomes of Acute Coronary Syndrome Patients Treated with Percutaneous Coronary Intervention: A Multi-center Study in Aomori

Scientific Title:Acronym

Aomori ACS Registry

Region

Japan


Condition

Condition

Acute coronary syndrome

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is improving the acute and chronic outcomes of ACS patients at Aomori prefecture.

Basic objectives2

Others

Basic objectives -Others

This study is retrospective and prospective research of clinical outcomes of acute coronary syndrome (ACS) patients treated with percutaneous coronary intervention (PCI) at Aomori prefecture.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We analyze the patient characteristics, clinical data, laboratory data, PCI procedure, medical therapy, and clinical event etc. in acute and chronic phase.

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

Acute coronary syndrome patients treated by PCI within 24 hours onset

Key exclusion criteria

none

Target sample size

4000


Research contact person

Name of lead principal investigator

1st name Hiroaki
Middle name
Last name Yokoyama

Organization

Hirosaki University Graduate School of Medicine

Division name

Advanced Cardiovascular Therapeutics

Zip code

036-8562

Address

5Zaifu-cho, Hirosaki, Japan

TEL

0172-39-5057

Email

hero8686@hirosaki-u.ac.jp


Public contact

Name of contact person

1st name Hiroaki
Middle name
Last name Yokoyama

Organization

Hirosaki University Graduate School of Medicine

Division name

Advanced Cardiovascular Therapeutics

Zip code

036-8562

Address

5Zaifu-cho, Hirosaki, Japan

TEL

0172-39-5057

Homepage URL


Email

hero8686@hirosaki-u.ac.jp


Sponsor or person

Institute

Hirosaki University Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

JP


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hirosaki University Graduate School of Medicine

Address

5Zaifu-cho, Hirosaki, Japan

Tel

0172-39-5194

Email

jm5194@cc.hirosaki-u.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 04 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 04 Month 01 Day

Date of IRB


Anticipated trial start date

2020 Year 04 Month 01 Day

Last follow-up date

2030 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is designed as retrospective and prospective multi-center study at Aomori prefecture.
All ACS patients treated by PCI within 24 hours onset are population of this study. We analyze the patient characteristics, clinical data, laboratory data, PCI procedure, medical therapy, and clinical event etc. in acute and chronic phase.


Management information

Registered date

2020 Year 03 Month 12 Day

Last modified on

2022 Year 03 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045378


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name