UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020083 |
|---|---|
| Receipt number | R000013656 |
| Scientific Title | To Explore the Usefulness of the Echocardiography Including Tissue Doppler Imaging in Patients with a ST Elevation Acute Myocardial Infarction During the Convalescent Stage |
| Date of disclosure of the study information | 2015/12/07 |
| Last modified on | 2015/12/05 20:10:53 |
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Basic information
Public title
To Explore the Usefulness of the Echocardiography Including Tissue Doppler Imaging in Patients with a ST Elevation Acute Myocardial Infarction During the Convalescent Stage
Acronym
T-AMI
Scientific Title
To Explore the Usefulness of the Echocardiography Including Tissue Doppler Imaging in Patients with a ST Elevation Acute Myocardial Infarction During the Convalescent Stage
Scientific Title:Acronym
T-AMI
Region
| Japan |
Condition
Condition
ST elavation acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the usefulness of echocardiography including tissue Doppler imaging during their convalescent stage in patients with ST elevation acute myocardial infarction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
cardiac death or hospitalization with heart failure
Key secondary outcomes
all cause death
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
All of these patients underwent reperfusion therapy with percutaneous coronary intervention within 12 hours of symptom onset.
Key exclusion criteria
Patients with a prior MI, atrial fibrillation, chronic renal failure on dialysis, unacceptable echocardiographic images, or emergency coronary artery bypass surgery were excluded
Target sample size
300
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-cho Minami-ku Yokohama, Japan
TEL
045-261-5656
iwahashi@ra2.so-net.ne.jp
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-cho Minami-ku Yokohama, Japan
TEL
045-261-5656
Homepage URL
iwahashi@ra2.so-net.ne.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Medical Center
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
2010ACC,The Combination of Inferior Vena Cava and E/e is a Powerful Index of the Deterioration of Renal Function and the Prognosis after a First ST-Elevation Acute Myocardial Infarction
E/e' two weeks after onset is a powerful predictor of cardiac death and heart failure in patients with a first-time ST elevation acute myocardial infarction.
Iwahashi N, Kimura K et al.
J Am Soc Echocardiogr. 2012 Dec;25:1290-8.
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
| 2005 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 04 | Month | 30 | Day |
Other
Other related information
E/e' at 2weeks after onset fo STEMI was useful.
Further analyses are being performed.
Management information
Registered date
| 2015 | Year | 12 | Month | 05 | Day |
Last modified on
| 2015 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013656
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
