UMIN-CTR Clinical Trial

Basic information
Public title	Demonstration of the Usefulness for the Evaluation by Real-time 3D Echocardiography, Speckle Tracking and tissue Doppler Echocardiography in Patients with a First ST-Elevation Acute Myocardial Infarction
Acronym	DUAL-ECHO
Scientific Title	Demonstration of the Usefulness for the Evaluation by Real-time 3D Echocardiography, Speckle Tracking and tissue Doppler Echocardiography in Patients with a First ST-Elevation Acute Myocardial Infarction
Scientific Title:Acronym	DUAL-ECHO
Region	Japan

Condition
Condition	Patients with first ST-elevation acute myocardial infarction(STEMI) who successfully underwent emergent PCI within 24 hours of onset.
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore the usefulness of real-time 3D echocardiography on the evaluation for a first STEMI. If possible, we were planning to perform tissue Doppler, speckle tracking echo and three dimensional speckle tracking echo. We had a lot of data who had 2 weeks after onset of AMI, therefore we will explore to resolve the difference of usefulness of tissue Doppler echo in terms of the results of these two reserch(24 hours after admission vs. 2weeks sfter onset).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	EF. EDV(I). ESV(I). BNP. Remodeling.
Key secondary outcomes	MACCE(Major adverse cardiac and cerebrovascular events).

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	Subjects who successfully underwent emergent PCI for their first STEMI within 12 hours of onset. Age is greater than 20 years-old.
Key exclusion criteria	1)Younger than 20 years old. 2)History of prior myocardial infarction. 3)Unstable angina pectoris after AMI. 4)According to the attending physician's judgment, because of patients' unconsciousness or dementia. 5)Impossible to obtain informed written consent. 6)Subjects with contraindication for CAG, such as patients with hypersensitivity to iodine. 7)History of prior PCI or CABG. 8)Subjects who could not undergo 99mTc MIBI.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Noriaki Middle name Last name Iwahashi
Organization	Yokohama City University Medical Center
Division name	Division of Cardiology
Zip code	232-0024
Address	4-57 Urafune-chou, Minami-ku, Yokohama.
TEL	045-261-5656
Email	niwahash@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Noriaki Middle name Last name Iwahashi
Organization	Yokohama City University Medical Center
Division name	Division of Cardiology
Zip code	232-0024
Address	4-57 Urafune-chou, Minami-ku, Yokohama.
TEL	045-261-5656
Homepage URL
Email	niwahash@urahp.yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	none
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	YCU novel and clinical trail center
Address	Fukuura Kanazawa-ku Yokohama
Tel	045-787-2800
Email	ynext@yokohama-cu.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	横浜市立大学付属市民総合医療センター Yokohama City University Medical Center

Other administrative information
Date of disclosure of the study information	2009 Year 04 Month 29 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	Completed
Date of protocol fixation	2008 Year 04 Month 01 Day
Date of IRB	2008 Year 04 Month 01 Day
Anticipated trial start date	2008 Year 04 Month 01 Day
Last follow-up date	2013 Year 03 Month 01 Day
Date of closure to data entry	2013 Year 09 Month 01 Day
Date trial data considered complete	2015 Year 12 Month 01 Day
Date analysis concluded	2020 Year 12 Month 31 Day

Other

Other related information

The purpose of this study is to explore the usefulness of real-time 3D echocardiography (RT3DE) on the evaluation for a first ST-elavation acute myocardial infarction(STEMI). Subjects are the patients with first STEMI who successfully underwent emergent PCI within 24 hours of onset. They will undergo 99mTc MIBI at 2 weeks. Furthermore, we will examine RT3DE after 10months repeatedly to measure their left ventricular size and function. We will explore if the measurements by RT3DE could predict left ventricular remodeling and prognosis of the patients after a first STEMI.

Management information
Registered date	2009 Year 04 Month 29 Day
Last modified on	2020 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=R000002335