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Recruitment status Completed
Unique ID issued by UMIN UMIN000011824
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email takayama@soiken.com

Sponsor
Institute Associations for Establishment of Evidence in Interventions (AEEI)
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013822


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