UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045503 |
|---|---|
| Receipt number | R000051949 |
| Scientific Title | Sources, Treatment, and outcome in Embolic stroke Patients with TransEsophageal Echocardiography study |
| Date of disclosure of the study information | 2021/09/17 |
| Last modified on | 2024/09/18 19:34:12 |
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Basic information
Public title
Sources, Treatment, and outcome in Embolic stroke Patients with TransEsophageal Echocardiography study
Acronym
STEP-TEE study
Scientific Title
Sources, Treatment, and outcome in Embolic stroke Patients with TransEsophageal Echocardiography study
Scientific Title:Acronym
STEP-TEE study
Region
| Japan |
Condition
Condition
Ischemic stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To unveil the real world data for sources, treatment, and outcome in embolic stroke pathents with transesophageal echocardiography
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
modified Rankin Scale
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
Ischemic stroke patients admitted within 7 days from onset
Ischemic stroke was confirmed by MRI or CT
TEE was procedured
Key exclusion criteria
Without TEE
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Fujimoto |
Organization
Jichi Medical University School of Medicine
Division name
Neurology
Zip code
329-0498
Address
Yakushiji 3311-1, Shimotsuke, Tochigi, Japan
TEL
0285-58-7352
shigeruf830@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Mashiko |
Organization
Jichi Medical University School of Medicine
Division name
Neurology
Zip code
329-0498
Address
Yakushiji 3311-1, Shimotsuke, Tochigi, Japan
TEL
0285-58-7352
Homepage URL
r0748tm@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
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
Jichi Medical University Hospital Clinical Research Ethics Committee
Address
Yakushiji 3311-1, Shimotsuke, Tochigi, Japan
Tel
0285-58-8933
rinri@jichi.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
| 2021 | Year | 09 | Month | 17 | 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
| 2021 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
a. Prevalence of risks with embolization according to the TOAST criteria; aortic arch plaque, right to left shunt, tumor and vegetation
b. Functional prognosis (modified Rankin Scale : mRS)
c. Recurrence of ischemic stroke
d. Stroke event
e. Cardiovascular event
f. Hemorrhagic event (intracranial hemorrhage, gastrointestinal bleeding, and others)
g. Death
Management information
Registered date
| 2021 | Year | 09 | Month | 17 | Day |
Last modified on
| 2024 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051949
