UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056921 |
|---|---|
| Receipt number | R000065051 |
| Scientific Title | Investigation of the Association Between Pericoronary Adipose Tissue Attenuation and the Temporal Changes in Plaque Characteristics Evaluated by Optical Coherence Tomography |
| Date of disclosure of the study information | 2025/05/10 |
| Last modified on | 2025/04/07 18:27:45 |
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Basic information
Public title
Investigation of the Association Between Pericoronary Adipose Tissue Attenuation and the Temporal Changes in Plaque Characteristics Evaluated by Optical Coherence Tomography
Acronym
Investigation of the Association Between Pericoronary Adipose Tissue Attenuation and the Temporal Changes in Plaque Characteristics Evaluated by Optical Coherence Tomography
Scientific Title
Investigation of the Association Between Pericoronary Adipose Tissue Attenuation and the Temporal Changes in Plaque Characteristics Evaluated by Optical Coherence Tomography
Scientific Title:Acronym
Investigation of the Association Between Pericoronary Adipose Tissue Attenuation and the Temporal Changes in Plaque Characteristics Evaluated by Optical Coherence Tomography
Region
| Japan |
Condition
Condition
Coronary Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the association between pericoronary adipose tissue attenuation (PCAT attenuation) obtained from coronary computed tomography angiography (cCTA) and the temporal changes in plaque characteristics assessed by optical coherence tomography (OCT).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Based on previous reports, patients are classified into two groups: the High PCAT attenuation group, defined as having a PCAT attenuation of -75 HU or higher, and the Low PCAT attenuation group, defined as having a PCAT attenuation of less than -75 HU. The change in fibrous cap thickness of the target lesion observed by OCT is compared between these two groups.
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
Patient Criteria
Patients who underwent follow-up coronary angiography (CAG) and optical coherence tomography (OCT) at least 3 months and within 24 months after baseline CAG and OCT.
Patients who underwent coronary computed tomography angiography (cCTA) within 5 months prior to baseline CAG and OCT.
Patients aged 20 years or older at the time of baseline CAG and OCT.
Lesion Criteria
Lesions with plaque showing a luminal area stenosis between 30% and 70% on baseline OCT evaluation.
Key exclusion criteria
Patients with stent placement in the proximal right coronary artery (<10 mm) or the left main coronary artery.
Patients with a history of coronary artery bypass grafting (CABG).
Patients for whom cCTA analysis is not feasible.
Patients for whom OCT analysis is not feasible.
Lesion Criteria
Lesions treated with percutaneous coronary intervention (PCI) at the time of baseline CAG and OCT (including within 5 mm of the treated segment).
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Iida |
Organization
Kobe University Hospital
Division name
Department of Cardiovascular Medicine, Division of Internal Medicine, Graduate School of Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-5846
wanhira@gmail.com
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Iida |
Organization
Kobe University Hospital
Division name
Department of Cardiovascular Medicine, Division of Internal Medicine, Graduate School of Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-5846
Homepage URL
wanhira@gmail.com
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospital Clinical and Translational Research Center
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
Tel
078-382-6669
chiken@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 | 05 | 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
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | 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
none
Management information
Registered date
| 2025 | Year | 02 | Month | 03 | Day |
Last modified on
| 2025 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065051
