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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025995
Receipt No. R000029688
Scientific Title Inappropriate implantable cardioverter-defibrillator therapy: Frequency, syncope and prognostic factors
Date of disclosure of the study information 2017/02/04
Last modified on 2017/01/25

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Basic information
Public title Inappropriate implantable cardioverter-defibrillator therapy:
Frequency, syncope and prognostic factors
Acronym Inappropriate ICD therapy survey
Scientific Title Inappropriate implantable cardioverter-defibrillator therapy:
Frequency, syncope and prognostic factors
Scientific Title:Acronym Inappropriate ICD therapy survey
Region
Japan

Condition
Condition Life-threatening arrhythmia
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the incidence of syncope related to inappropriate ICD therapies.
Basic objectives2 Others
Basic objectives -Others To clarify the prognostic factors in patients who had inappropriate ICD therapies.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The incidence of syncope related to inappropriate ICD therapies.
Key secondary outcomes The prognostic factors in patients who had inappropriate ICD therapies.

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria To be enrolled, patients had to: (1) have an indication for ICD or CRT-D implantation according to the JCS Guidelines for Device-based Therapy of Cardiac Rhythm Abnormalities (2) be able to visit scheduled outpatient department and (3) be able to comply with the study protocol.
Key exclusion criteria Patient exclusion criteria were no information on the medical condition, refused enrollment of this study.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiichi Watanabe
Organization Fujita Health University School of Medicine
Division name Department of Cardiology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi 470-1192
TEL 0562-93-2312
Email enwatan@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiichi Watanabe
Organization Fujita Health University School of Medicine
Division name Department of Cardiology
Zip code
Address 1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi 470-1192
TEL 0562-93-2312
Homepage URL
Email enwatan@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization Fujita Health University School of Medicine
Organization
Division
Category of Funding Organization Other
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
2017 Year 02 Month 04 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
2014 Year 10 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We examined 772 inappropriate ICD therapies occurring in 417 patients (age 61+/-15 years, primary prevention 65%). Patients experiencing an inappropriate therapy had a mean number of 1.8+/-1.5 therapy episodes during the mean follow-up period of 5.2 years. Only 3 patients (0.7%) experienced syncope associated with inappropriate therapies.

Management information
Registered date
2017 Year 02 Month 03 Day
Last modified on
2017 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029688

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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