UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062129 |
|---|---|
| Receipt number | R000071092 |
| Scientific Title | Pathological significance of monosodium urate (MSU) crystal deposition in abdominal aortic aneurysm walls: a prospective observational study on concordance between dual-energy CT and histopathological findings with local inflammatory assessment |
| Date of disclosure of the study information | 2026/07/06 |
| Last modified on | 2026/07/02 23:17:08 |
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Basic information
Public title
A prospective observational study on monosodium urate crystal deposition and local inflammation in the wall of abdominal aortic aneurysms
Acronym
MSU-AAA Study
Scientific Title
Pathological significance of monosodium urate (MSU) crystal deposition in abdominal aortic aneurysm walls: a prospective observational study on concordance between dual-energy CT and histopathological findings with local inflammatory assessment
Scientific Title:Acronym
MSU-AAA Study
Region
| Japan |
Condition
Condition
Abdominal aortic aneurysm
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Vascular surgery |
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively compare preoperative dual-energy CT assessment of monosodium urate (MSU) crystal deposition with histopathological MSU identification performed by polarized light microscopy of hematoxylin-eosin (HE)-stained and De Galantha-stained sections from surgically resected specimens in patients undergoing open surgical repair for abdominal aortic aneurysm, and to evaluate concordance and local inflammatory findings.
Basic objectives2
Others
Basic objectives -Others
To determine the prevalence of MSU crystal deposition in abdominal aortic aneurysm walls and its association with hyperuricemia and serum uric acid levels, and to examine whether MSU crystals directly contribute to atherosclerotic progression.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Concordance rate (assessed by McNemar test) between MSU deposition positivity on preoperative dual-energy CT (DECT, performed on the day of or the day before surgery) and histopathological MSU positivity assessed by polarized light microscopy of HE-stained and De Galantha-stained sections from aortic wall specimens resected during open surgical repair
Key secondary outcomes
(1) Association between histopathological MSU positivity in resected specimens and serum uric acid level (mg/dL) measured at preoperative blood sampling (on the day of or the day before surgery), history of gout, and hyperuricemia (serum uric acid >=7.0 mg/dL) confirmed by preoperative interview
(2) Comparison of preoperative serum uric acid levels (mg/dL) between MSU-positive and MSU-negative groups, measured at preoperative blood sampling (on the day of or the day before surgery)
(3) Association between the presence or absence of local inflammatory cell infiltration assessed by polarized light microscopy of HE-stained sections and MSU positivity in resected specimens (assessed at histopathological evaluation after resection)
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 undergoing open surgical repair for abdominal aortic aneurysm at the Department of Cardiovascular Surgery, Dokkyo Medical University Hospital
(2) Patients from whom cardiovascular tissue containing atherosclerotic lesions can be obtained during surgery
(3) Patients who have received sufficient explanation of this study and provided written informed consent
Key exclusion criteria
Patients deemed inappropriate for study participation by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeru |
| Middle name | |
| Last name | Nakamura |
Organization
Dokkyo Medical University Hospital
Division name
Department of Cardiovascular Surgery
Zip code
3210207
Address
880 Kitakobayashi, Mibu City, Tochigi 321-0298, Japan
TEL
0282-86-1111
nakamura994@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Takeru |
| Middle name | |
| Last name | Nakamura |
Organization
Dokkyo Medical University Hospital
Division name
Department of Cardiovascular Surgery
Zip code
3210207
Address
880 Kitakobayashi, Mibu City, Tochigi 321-0298, Japan
TEL
0282-86-1111
Homepage URL
nakamura994@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Takeru Nakamura
Funding Source
Organization
Dokkyo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Dokkyo Medical University Hospital
Address
880 Kitakobayashi, Mibu City, Tochigi 321-0298, Japan
Tel
0282-87-2275
kenkyu@dokkyomed.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
| 2026 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center prospective study enrolling patients undergoing open surgical repair for abdominal aortic aneurysm. Preoperative dual-energy CT (DECT) is performed between 6 months before and the day before surgery to assess MSU crystal deposition. Aortic aneurysm wall tissue (1 to 25 cm2) harvested during surgery is stained with HE and De Galantha stain and examined under polarized light microscopy (200 to 400x magnification) to identify MSU crystals. The primary evaluation assesses concordance between DECT and histopathological MSU identification using the McNemar test. Secondary evaluations include the association between MSU positivity and serum uric acid levels, hyperuricemia, or history of gout, and the relationship between local inflammatory cell infiltration and MSU positivity. IRB approval number: R-106-1.
Management information
Registered date
| 2026 | Year | 07 | Month | 02 | Day |
Last modified on
| 2026 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071092
