UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059015 |
|---|---|
| Receipt number | R000067220 |
| Scientific Title | Clinical management algorithm for embolic stroke of undetermined source |
| Date of disclosure of the study information | 2025/09/06 |
| Last modified on | 2025/09/06 01:05:00 |
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Basic information
Public title
Clinical management algorithm for embolic stroke of undetermined source
Acronym
ALGO-ESUS
Scientific Title
Clinical management algorithm for embolic stroke of undetermined source
Scientific Title:Acronym
ALGO-ESUS
Region
| Japan |
Condition
Condition
Embolic stroke of undetermined source (ESUS)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the recurrence rate and treatment responsiveness in patients with embolic stroke of undetermined source (ESUS) based on their clinical background and risk factors. In addition, the safety of percutaneous patent foramen ovale (PFO) closure will be evaluated in patients with PFO.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Incidence of recurrent stroke during follow-up
2. Characteristics of patients with implantable loop recorders or electrocardiogram patch monitors
3. Timing of atrial fibrillation detection and atrial fibrillation burden
Key secondary outcomes
1. Timing of atrial fibrillation detection and AF burden after PFO closure
2. Antithrombotic therapy and ischemic or bleeding events after percutaneous PFO closure
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
1. Patients who experienced an ischemic stroke between January 2021 and April 2025 and visited or were admitted to the participating institution.
2. Patients diagnosed with embolic stroke of undetermined source.
Key exclusion criteria
Patients who did not consent to participate.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Junji |
| Middle name | |
| Last name | Takasugi |
Organization
The University of Osaka Graduate School of Medicine
Division name
Department of Neurology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita City, Osaka, Japan
TEL
06-6879-3571
takasugi@neurol.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Junji |
| Middle name | |
| Last name | Takasugi |
Organization
The University of Osaka Graduate School of Medicine
Division name
Department of Neurology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita City, Osaka, Japan
TEL
06-6879-3571
Homepage URL
takasugi@neurol.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nakatani Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Osaka Hospital Ethical Review Board
Address
2-2, Yamadaoka, Suita-city, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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
| 2025 | Year | 09 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 20 | 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 multicenter observational study conducted in Japan
Management information
Registered date
| 2025 | Year | 09 | Month | 06 | Day |
Last modified on
| 2025 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067220
