UMIN-CTR Clinical Trial

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
Institute	Hirosaki University Hospital
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045378