UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061857 |
|---|---|
| Receipt number | R000070779 |
| Scientific Title | Incremental diagnostic value of pericoronary adipose tissue attenuation for the detection of vulnerable plaques |
| Date of disclosure of the study information | 2026/06/10 |
| Last modified on | 2026/06/10 13:26:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Incremental diagnostic value of pericoronary adipose tissue attenuation for the detection of vulnerable plaques
Acronym
Pericoronary adipose tissue attenuation for identification of vulnerable plaques
Scientific Title
Incremental diagnostic value of pericoronary adipose tissue attenuation for the detection of vulnerable plaques
Scientific Title:Acronym
Incremental diagnostic value of pericoronary adipose tissue attenuation for the detection of vulnerable plaques
Region
| Japan |
Condition
Condition
Acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study also aims to evaluate whether adding PCAT attenuation to morphological and physiological CT-derived indices improves the discrimination and reclassification of ACS culprit lesions with plaque rupture.
Basic objectives2
Others
Basic objectives -Others
This study aims to investigate whether pericoronary adipose tissue (PCAT) attenuation provides incremental diagnostic value beyond morphological and physiological CT-derived indices for detecting vulnerable plaques associated with the development of acute coronary syndrome.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether the target lesion was identified as the ACS culprit lesion associated with plaque rupture
Key secondary outcomes
Differences in PCAT attenuation between ACS culprit lesions with plaque rupture and non-culprit lesions
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who developed acute coronary syndrome (ACS) due to plaque rupture as defined by percutaneous coronary intervention performed at the participating institutions between January 1, 2016 and December 31, 2025.
2. Patients in whom plaque rupture at the culprit lesion was identified by intravascular imaging, including intravascular ultrasound and/or optical coherence tomography, at the time of ACS.
2. Among the above patients, those who underwent coronary CT between 1 month and 2 years before the onset of ACS.
Key exclusion criteria
1. Patients who developed ACS due to restenosis-related lesions.
2. Patients who underwent coronary artery bypass grafting.
3. Patients with inadequate image quality on coronary CT.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takayoshi |
| Middle name | |
| Last name | Toba |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-5846
taka02222003@gmail.com
Public contact
Name of contact person
| 1st name | Takayoshi |
| Middle name | |
| Last name | Toba |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5846
Homepage URL
taka02222003@gmail.com
Sponsor or person
Institute
Others
Institute
Department
Personal name
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
Kobe University Hospital Clinical & Translational Research Center
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
Tel
078-382-6669
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
| 2026 | Year | 06 | Month | 10 | 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 | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a single-center retrospective observational study conducted by Kobe University Hospital as the research institution, using existing information provided by institutions that will only provide such information. The use of existing information is scheduled to begin on August 1, 2026, and the planned sample size is 150 patients.
Management information
Registered date
| 2026 | Year | 06 | Month | 10 | Day |
Last modified on
| 2026 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070779
