UMIN-CTR Clinical Trial

Basic information
Public title	The prevalence and predictor of ventricular arrhythmias for post myocardial infarction patients
Acronym	Chiba-MARIN study
Scientific Title	The prevalence and predictor of ventricular arrhythmias for post myocardial infarction patients
Scientific Title:Acronym	Chiba-MARIN study
Region	Japan

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

Objectives
Narrative objectives1	This study was designed to determine the prevalence and predictor of late-phase ventricular arrhythmias for post myocardial infarction patients.
Basic objectives2	Others
Basic objectives -Others	Ventricular arrhythmias are severe complications of acute myocardial infarction and associated with a high mortality. If we determine the predictor of ventricular arrhythmias, we can consider intensive medication and implantable carioverter defibrillator implantation aggressively.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Ventricular arrhythmias more than seven days after myocardial infarction onset
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Acute myocardial infarction patients who were older than 20 years of age, and all the patients provided written informed consent.
Key exclusion criteria	Patients who were less than 20 years of age, or refused to participate.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Yoshio Middle name Last name Kobayashi
Organization	Chiba University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Zip code	260-0856
Address	1-8-1 Inohana Chuou-ku Chiba
TEL	043-226-2675
Email	yoshio.kobayashi@wonder.ocn.ne.jp

Public contact
Name of contact person	1st name Masashi Middle name Last name Takahashi
Organization	Chiba University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Zip code	260-0856
Address	1-8-1 Inohana Chuou-ku Chiba
TEL	043-226-2675
Homepage URL
Email	m040055@yahoo.co.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Self funding
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	Chiba University Graduate School of Medicine General Affairs Department
Address	1-8-1 Inohana Chuou-ku Chiba
Tel	043-226-2501
Email	igaku-rinri@office.chiba-u.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	2017 Year 11 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	97
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	2016 Year 06 Month 30 Day
Date of IRB	2016 Year 10 Month 12 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date	2021 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective cohort study. Acute myocardial infarction patients who were older than 20 years of age, and all the patients provided written informed consent. We analyze the prevalence of ventricular arrhythmias for post myocardial infarction, and the relevance between ventricular arrhythmias and inspection results such as blood tests, echocardiography, or cardiac nuclear medicine examination.

Management information
Registered date	2017 Year 11 Month 01 Day
Last modified on	2021 Year 11 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028858