UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062552 |
|---|---|
| Receipt number | R000071603 |
| Scientific Title | Spatial concordance between pre-rupture CT-based computational fluid dynamics/finite element analysis and actual rupture sites in ruptured abdominal aortic aneurysm: a single-center retrospective observational study |
| Date of disclosure of the study information | 2026/08/11 |
| Last modified on | 2026/08/11 14:33:48 |
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Basic information
Public title
CT-based blood flow and structural analysis to identify rupture-prone regions of abdominal aortic aneurysm
Acronym
Mechanical imaging analysis of AAA rupture site
Scientific Title
Spatial concordance between pre-rupture CT-based computational fluid dynamics/finite element analysis and actual rupture sites in ruptured abdominal aortic aneurysm: a single-center retrospective observational study
Scientific Title:Acronym
CFD/FEA rupture-site concordance study in AAA
Region
| Japan |
Condition
Condition
Abdominal aortic aneurysm (including ruptured abdominal aortic aneurysm)
Classification by specialty
| Radiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively verify whether the high-risk regions (e.g., peak wall stress sites) estimated by computational fluid dynamics (CFD) and finite element analysis (FEA) of pre-rupture CT images spatially correspond to the actual rupture site in patients with ruptured abdominal aortic aneurysm.
Basic objectives2
Others
Basic objectives -Others
Validation of the predictive performance (predictive accuracy) of image-based biomechanical analysis for identifying the rupture site
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Spatial concordance rate between the high-risk region (peak wall stress site) predicted by CFD/FEA analysis of pre-rupture CT and the actual rupture site identified on CT at the time of rupture and/or operative findings. Assessment: analysis results based on the pre-rupture CT are compared with imaging and operative findings obtained at the time of rupture.
Key secondary outcomes
1) Distance (mm) between the predicted site and the actual rupture site; 2) peak wall stress and peak wall stress/wall strength ratio (rupture potential index); 3) hemodynamic indices such as time-averaged wall shear stress (TAWSS) and oscillatory shear index (OSI); 4) association with maximum aneurysm diameter and morphology (intraluminal thrombus volume, eccentricity, tortuosity); 5) interval from pre-rupture CT to rupture; 6) inter- and intra-observer reproducibility of the analyses and of rupture site determination. All items are assessed in all retrospectively collected cases.
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
1) Patients diagnosed with rupture of an abdominal aortic aneurysm (ruptured abdominal aortic aneurysm).
2) Patients in whom CT including the abdomen was performed before the rupture, with available DICOM data of sufficient quality (e.g., slice thickness 2 mm or less) for computational fluid dynamics (CFD) and finite element analysis (FEA).
3) Patients in whom the actual rupture site can be identified on CT obtained at the time of rupture and/or by operative findings.
4) Patients aged 20 years or older at diagnosis.
Key exclusion criteria
1) Patients without pre-rupture CT, or those whose image quality is inadequate for analysis.
2) Patients with aneurysms other than true abdominal aortic aneurysm, such as infectious or inflammatory aneurysm, traumatic aortic injury, aneurysm associated with aortic dissection, or anastomotic pseudoaneurysm.
3) Patients in whom the rupture site cannot be identified from imaging or operative findings.
4) Patients who had undergone repair of the abdominal aortic aneurysm (endovascular aneurysm repair or open graft replacement) before the rupture.
5) Patients (or their legal representatives) who declined the use of their clinical and imaging data for this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Nakajima |
Organization
Sapporo Medical University
Division name
Division of Cardiovascular Surgery, Department of Surgery
Zip code
060-8543
Address
South 1 West 16, Chuo-ku, Sapporo, Hokkaido 060-8543, Japan
TEL
011-611-2111
t.nakajima@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Nakajima |
Organization
Sapporo Medical University
Division name
Division of Cardiovascular Surgery, Department of Surgery
Zip code
060-8543
Address
South 1 West 16, Chuo-ku, Sapporo, Hokkaido 060-8543, Japan
TEL
011-611-2111
Homepage URL
t.nakajima@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Sapporo Medical University Hospital
Address
South 1 West 16, Chuo-ku, Sapporo, Hokkaido 060-8543, Japan
Tel
011-611-2111
rskk@sapmed.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
札幌医科大学附属病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 11 | 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
| 2026 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2028 | Year | 06 | Month | 30 | Day |
Other
Other related information
This is a single-center retrospective observational study using existing clinical and imaging data. No new participant recruitment or study-specific intervention will be performed.
Management information
Registered date
| 2026 | Year | 08 | Month | 11 | Day |
Last modified on
| 2026 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071603
