UMIN-CTR Clinical Trial

Basic information
Public title	Plasma xantine oxidoreductase (XOR) activity in patients with acute myocardial infarction
Acronym	Acute myocardial infarction and plasma XOR activity
Scientific Title	Plasma xantine oxidoreductase (XOR) activity in patients with acute myocardial infarction
Scientific Title:Acronym	Acute myocardial infarction and plasma XOR activity
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the clinical significance of plasma xantine oxidoreductase levels in patients with acute myocardial infarction.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationships between plasma xantine oxidoreductase activity and prognosis in patients with acute myocardial infarction
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	1)Patiets who admitted to our hospital diagnosed with acute myocardial infarction and emergent coronary intervention was performed. 2)Patients who give written informed consent.
Key exclusion criteria	1)Patinets who the physician judged to be inappropriate to this study. 2)The patient who withdrew informed consent.
Target sample size	30

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	Department of Cardiology
Zip code	036-8562
Address	5 Zaifu-cho Hirosaki, Aomori
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	Department of Cardiology
Zip code	036-8562
Address	5 Zaifu-cho Hirosaki, Aomori
TEL	0172-39-5057
Homepage URL
Email	hero8686@hirosaki-u.ac.jp

Sponsor
Institute	Department of Cardiology, Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Hirosaki University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Sanwa Kagaku Kenkyusyo Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hirosaki University Certified Review Board
Address	1 Bunkyo-sho, Hirosaki
Tel	0172-39-5362
Email	crb-hirosaki@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	弘前大学医学部附属病院(青森県)

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 17 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	50
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Under making Manuscript.
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	2016 Year 01 Month 14 Day
Date of IRB	2016 Year 04 Month 04 Day
Anticipated trial start date	2016 Year 04 Month 04 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study design: Observation Objective recruitment: Patients who admitted to our hospital diagnosed with acute myocardial infarction and emergent coronary intervention was performed. Primary outcome: Relationships between plasma xantine oxidoreductase activity and prognosis in patients with acute myocardial infarction.

Management information
Registered date	2016 Year 06 Month 17 Day
Last modified on	2021 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026253