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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001917
Receipt No. R000002335
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
Date of disclosure of the study information 2009/04/29
Last modified on 2015/12/04

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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
Middle name
Last name Noriaki Iwahashi
Organization Yokohama City University Medical Center
Division name Division of Cardiology
Zip code
Address 4-57 Urafune-chou, Minami-ku, Yokohama.
TEL 045-261-5656
Email

Public contact
Name of contact person
1st name
Middle name
Last name Noriaki Iwahashi
Organization Yokohama City University Medical Center
Division name Division of Cardiology
Zip code
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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2008 Year 04 Month 01 Day
Date of IRB
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
2015 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
2015 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002335

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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