UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001917 |
|---|---|
| Receipt number | 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 | 2020/11/06 16:54:54 |
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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 | 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
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
niwahash@urahp.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002335
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