UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056271 |
|---|---|
| Receipt number | R000064157 |
| Scientific Title | Epidemiological study of infective endocarditis cases in Japan over 1 year. |
| Date of disclosure of the study information | 2024/11/26 |
| Last modified on | 2026/02/13 10:52:42 |
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Basic information
Public title
Epidemiological study of infective endocarditis cases in Japan over 1 year.
Acronym
Epidemiological study of infective endocarditis cases in Japan over 1 year.
Scientific Title
Epidemiological study of infective endocarditis cases in Japan over 1 year.
Scientific Title:Acronym
Epidemiological study of infective endocarditis cases in Japan over 1 year.
Region
| Japan |
Condition
Condition
Infective Endocarditis
Classification by specialty
| Medicine in general | Cardiology | Neurology |
| Infectious disease | Surgery in general | Vascular surgery |
| Radiology | Neurosurgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the characteristics of patients with infective endocarditis in Japan, surgical and/or antimicrobial treatment and patient prognosis.
Basic objectives2
Others
Basic objectives -Others
Investigation of prognostic factors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In-hospital mortality
Key secondary outcomes
90-day mortality
The recurrence within 90days
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
Patients with a definite diagnosis of infective endocarditis from January 2023 to March 2024 were included.
Key exclusion criteria
Patients under the age of 18.
Patients with Healed IE.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Mitsutake |
Organization
Saitama Medical University International Medical Center
Division name
Division of Infectious Diseases and Infection Control
Zip code
3501298
Address
1397-1, Yamane, Hidaka City, Saitama, Japan
TEL
0429844111
kmitsuta@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Natsuki |
| Middle name | |
| Last name | Shinya |
Organization
Saitama Medical University International Medical Center
Division name
Infection Control Center
Zip code
3501298
Address
1397-1, Yamane, Hidaka City, Saitama, Japan
TEL
0429844111
Homepage URL
282_ie_jpn@5931.saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Kotaro Mitsutake
Funding Source
Organization
Saitama Medical University International Medical Center
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
Saitama Medical University International Medical Center IRB
Address
1397-1, Yamane, Hidaka City, Saitama, Japan
Tel
0429844523
chikens@saitama-med.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 | 11 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-Study design observation study(multi-institution)
-Research period: Apr.1,2023 to Mar.31,2024
-Survey items:
-The number of hospital beds in a facility
-Patient characteristics; age, sex, comorbidities, clinical complications
-Diagnosis; Community-acquired/nosocomial/health care-associated IE, infected lesion, echocardiographic findings, causative pathogens
-Treatment; surgery, antimicrobial therapy
-Outcome; In-hospital and 90-day mortality, recurrence within 90days
Management information
Registered date
| 2024 | Year | 11 | Month | 26 | Day |
Last modified on
| 2026 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064157
