UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056744 |
|---|---|
| Receipt number | R000064849 |
| Scientific Title | Association between Perivascular Adipose Tissue Attenuation and Outcomes After Endovascular Aortic Repair |
| Date of disclosure of the study information | 2025/01/17 |
| Last modified on | 2025/01/17 15:27:19 |
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Basic information
Public title
Association between Perivascular Adipose Tissue Attenuation and Outcomes After Endovascular Aortic Repair
Acronym
Association between Perivascular Adipose Tissue Attenuation and Outcomes After Endovascular Aortic Repair
Scientific Title
Association between Perivascular Adipose Tissue Attenuation and Outcomes After Endovascular Aortic Repair
Scientific Title:Acronym
Association between Perivascular Adipose Tissue Attenuation and Outcomes After Endovascular Aortic Repair
Region
| Japan |
Condition
Condition
Abdominal aortic aneurysm
Classification by specialty
| Cardiology | Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We sought to examine the association between vascular inflammation, as assessed by PVAT attenuation measured before EVAR, and subsequent clinical outcomes following EVAR.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this study was the cumulative incidence of major adverse cardiac or cerebrovascular events (MACCE), defined as a composite of all-cause death, myocardial infarction (MI), stroke, and any vessel treatment.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were as follows: (1) patients who underwent EVAR for unruptured AAA, and (2) patients who underwent CTA within 180 days before EVAR.
Key exclusion criteria
The exclusion criteria were as follows: (1) patients who had prior AAA treatment, (2) patients with insufficient CT data quality, (3) patients who underwent CTA at the acute stage of other diseases, (4) patients with dissecting aneurysms, (5) patients with infected aneurysms, (6) patients with prognosis determined by other diseases, (7) patients with less than one year of follow-up after EVAR, and (8) patients underwent CTA at less than 100kvp tube voltage.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Otake |
Organization
Kobe University Hospital, School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
6520017
Address
5-2, Kusunokucho 7-chome, Chuo-ku, Kobe-shi, Hyogo
TEL
078-382-5846
hotake@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromasa |
| Middle name | |
| Last name | Otake |
Organization
Kobe University Hospital, School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
6500017
Address
5-2, Kusunokucho 7-chome, Chuo-ku, Kobe-shi, Hyogo
TEL
078-382-5846
Homepage URL
hotake@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
no organization
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
Secretariat of Medical Ethics Committee (Observational Research), Division of Research Ethics, Center for Clinical Research Promotion, Kobe University Hospital
Address
5-2, Kusunokucho 7-chome, Chuo, Kobe, Hyogo
Tel
0783825111
kansatsu@med.kobe-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 | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | 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
none
Management information
Registered date
| 2025 | Year | 01 | Month | 17 | Day |
Last modified on
| 2025 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064849
