UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the plasma adenosine mobilization in patients with acute myocardial infarction.
Title of the study (Brief title)	ADENOSINE-AMI
Region	Japan

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

Objectives
Narrative objectives1	Investigate the relationship between mobilized adenosine and left ventricular remodeling in patients with acute myocardial infarction.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The number of mobilized adenosine concentration and effect on 6 months later left ventricular remodeling 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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with acute myocardial infarction. Patients with significant coronary artery stenosis . Patients without significant coronary stenosis.
Key exclusion criteria	Patients whom the doctor decided not to include because of various reasons.
Target sample size	100

Research contact person
Name of lead principal investigator	Toshiki Tanaka
Organization	Gifu University
Division name	Department of Cardiology
Address	Yanagido 1-1, Gifu, Gifu
TEL	058-230-6520
Email	toshizo@gifu-u.ac.jp

Public contact
Name of contact person	Toshiki Tanaka
Organization	Gifu University
Division name	Department of Cardiology
Address	Yanagido 1-1, Gifu, Gifu
TEL	058-230-6520
Homepage URL
Email	toshizo@gifu-u.ac.jp

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

Funding Source
Organization	Department of Cardiology, Gifu University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Japanese Red Cross Takayama Hospital
Name of secondary funｄer(s)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 01 Month 06 Day
Anticipated trial start date	2016 Year 01 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Patients who were admitted to Gifu University Hospital & Japanese Red Cross Takayama Hospital were included in this study. Diagnosis of AMI was defined based on the presence of prolonged anterior chest pain, ST segment elevation in electrocardiogram, and an occluded coronary artery by coronary angiography. AMI patients were treated with percutaneous coronary intervention followed by standard pharmacological treatment, such as anti-platelet therapy.

Management information
Registered date	2018 Year 08 Month 29 Day
Last modified on	2018 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038711