UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060475 |
|---|---|
| Receipt number | R000069186 |
| Scientific Title | External validation of the SPAU2 score for 1-year risk stratification in acute type A intramural hematoma: a temporally distinct single-center cohort study |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2026/01/27 08:09:05 |
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Basic information
Public title
External validation of the SPAU2 score for 1-year risk stratification in acute type A intramural hematoma: a temporally distinct single-center cohort study
Acronym
External validation of the risk score for acute type A intramural hematoma
Scientific Title
External validation of the SPAU2 score for 1-year risk stratification in acute type A intramural hematoma: a temporally distinct single-center cohort study
Scientific Title:Acronym
External validation of the risk score for acute type A intramural hematoma
Region
| Japan |
Condition
Condition
acute type A intramural hematoma
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To externally validate the SPAU2 score in a newly established, temporally distinct cohort from the same institution.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cardiovascular death or operation within 1-year after onset of type A IMH
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Consecutive acute type A intramural hematoma patients who received initial medical management
Key exclusion criteria
those who received urgent surgery
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shigetaka |
| Middle name | |
| Last name | Kageyama |
Organization
Shizuoka City Shizuoka Hospital
Division name
Department of Cardiology
Zip code
4208630
Address
10-93 Ohtemachi Aoi-ku Shizuoka
TEL
054-253-3125
shigenewf@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shigetaka |
| Middle name | |
| Last name | Kageyama |
Organization
Shizuoka City Shizuoka Hospital
Division name
Department of Cardiology
Zip code
4208630
Address
10-93 Ohtemachi Aoi-ku Shizuoka
TEL
0542533125
Homepage URL
shigenewf@yahoo.co.jp
Sponsor or person
Institute
Shizuoka City Shizuoka Hospital
Institute
Department
Personal name
SHIGETAKA KAGEYAMA
Funding Source
Organization
none
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
Shizuoka City Shizuoka Hospital
Address
10-93 Ohtemachi Aoi-ku Shizuoka
Tel
054-253-3125
chiken2@shizuokahospital.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
| 2026 | Year | 02 | Month | 01 | 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
85
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
| 2007 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 01 | Month | 27 | Day |
Last modified on
| 2026 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069186
