UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011824 |
|---|---|
| Receipt number | R000013822 |
| Scientific Title | The Evaluation of the ST Segment Using the Automatic Monitoring Function |
| Date of disclosure of the study information | 2013/09/20 |
| Last modified on | 2015/09/20 17:41:05 |
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Basic information
Public title
The Evaluation of the ST Segment Using the Automatic Monitoring Function
Acronym
ESTIMATION
Scientific Title
The Evaluation of the ST Segment Using the Automatic Monitoring Function
Scientific Title:Acronym
ESTIMATION
Region
| Japan |
Condition
Condition
Ischemic Cardiac Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To observe continuous ST changes by intracardiac Electrogram (EGM) and to investigate the effectiveness of setting the recommendation value.
2. To investigate the involvement of myocardial ischemia in the episode of ventricular tachycardia and ventricular fibrillation
3. To investigate that shock therapy triggers the exacerbation of myocardial ischemia or the cause of myocardial disorder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. To observe continuous ST changes by intracardiac Electrogram (EGM) and to investigate the effectiveness of setting the recommendation value.
2. To investigate the involvement of myocardial ischemia in the episode of ventricular tachycardia and ventricular fibrillation
3. To investigate that shock therapy triggers the exacerbation of myocardial ischemia or the cause of myocardial disorder.
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
1. The patients who have been implanted or have scheduled to implant ICD attached with ST monitoring function
2. The patients with a previous history of ischemic cardiac disease
Key exclusion criteria
1. The patients who is complete atrioventricular block (the patients who will implant atrial pacing definitely).
2. Under age 20.
3. Patients who are considered inappropriate for enrollment in this study, such as patients who cannot follow clinical research enough (limited life expectancy, mental disorder)
4. The patients who Brugada syndrome.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Watanabe |
Organization
Yao Municipal Hospital
Division name
Department of Cardiology
Zip code
Address
1-3-1, Ryugecho, Yao-city, Osaka, 581-0069, Japan
TEL
+81-72-922-0881
t.watanabe252@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Takayama |
Organization
Soiken Inc.
Division name
Division of Clinical Study Support
Zip code
Address
1-4-2, Shin-Senri Higashimachi, Toyonaka, Osaka
TEL
03-3295-1376
Homepage URL
takayama@soiken.com
Sponsor or person
Institute
Associations for Establishment of Evidence in Interventions (AEEI)
Institute
Department
Personal name
Funding Source
Organization
Associations for Establishment of Evidence in Interventions(AEEI)
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
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
| 2013 | Year | 09 | Month | 20 | 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
| 2011 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To perform a multicenter clinical study with an aim to clarify the
effectiveness of continuous ST monitoring comparing with the
traditional diagnostic methods among the patients who have been
implanted ICD attached with a continuous ST monitoring feature.
Management information
Registered date
| 2013 | Year | 09 | Month | 20 | Day |
Last modified on
| 2015 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013822
| 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 |
