UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054673 |
|---|---|
| Receipt number | R000062476 |
| Scientific Title | Establishment of the Screening System for Standarlization of Primary ICD Implantation |
| Date of disclosure of the study information | 2024/06/16 |
| Last modified on | 2024/06/16 15:33:41 |
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Basic information
Public title
Establishment of the Screening System for Standarlization of Primary ICD Implantation
Acronym
EST-SSS trial
Scientific Title
Establishment of the Screening System for Standarlization of Primary ICD Implantation
Scientific Title:Acronym
EST-SSS trial
Region
| Japan |
Condition
Condition
Ventricular tachycardia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To systematically and uniformly identify Class I and Class IIa candidates for ICD as primary prevention in Yamanashi Prefecture, and to establish a comprehensive system ensuring appropriate implantation of ICD for patients who require it.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatal arrhythmic events and death.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
From May 1, 2024 to Octorber 31, 2025, individuals meeting the following criteria who underwent echocardiography at various hospitals in Yamanashi Prefecture are included:
1) Left ventricular ejection fraction (LVEF) less or 40%
2) Age 20 years or older and younger than 85 years
Key exclusion criteria
Patients meeting any of the following criteria are excluded from the study:
1) Patients with physical functional limitations due to chronic illnesses.
2) Patients diagnosed with a life expectancy of less than 1 year due to any illness.
3) Patients with severe congestive heart failure resistant to medical treatment (NYHA class IV) who are not candidates for heart transplantation, CRT, or left ventricular assist device (LAVD).
4) Pregnant patients.
5) Patients deemed unsuitable for participation in the study by their attending physician for any other reasons.
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Kuroki |
Organization
University of Yamanashi
Division name
Department of Cardiology
Zip code
409-3898
Address
1110 Shimokato, Chuo, Yamanashi
TEL
0552739590
kkuroki@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Kuroki |
Organization
University of Yamanashi
Division name
Department of Cardiology
Zip code
409-3898
Address
1110 Shimokato, Chuo, Yamanashi
TEL
055-273-9590
Homepage URL
kkuroki@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi
Institute
Department
Personal name
Kenji Kuroki
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Yamanashi Ethics Committee
Address
1110 Shimokato, Chuo, Yamanashi
Tel
055-273-9590
kkuroki@yamanashi.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 06 | Month | 16 | Day |
Last modified on
| 2024 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062476
