UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000058675 |
|---|---|
| Receipt number | R000066944 |
| Scientific Title | Assessment of Pericoronary Adipose Tissue Attenuation and Its Diagnostic Utility in Coronary Microvascular Dysfunction |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/08/09 20:17:55 |
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Basic information
Public title
Assessment of Pericoronary Adipose Tissue Attenuation and Its Diagnostic Utility in Coronary Microvascular Dysfunction
Acronym
Assessment of Pericoronary Adipose Tissue Attenuation and Its Diagnostic Utility in Coronary Microvascular Dysfunction
Scientific Title
Assessment of Pericoronary Adipose Tissue Attenuation and Its Diagnostic Utility in Coronary Microvascular Dysfunction
Scientific Title:Acronym
Assessment of Pericoronary Adipose Tissue Attenuation and Its Diagnostic Utility in Coronary Microvascular Dysfunction
Region
| Japan |
Condition
Condition
coronary microvascular dysfunction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the association between CT value attenuation of pericoronary adipose tissue assessed using coronary CT and coronary microcirculatory impairment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnosis of coronary microcirculatory impairment by attenuation of CT values of pericoronary adipose tissue measured by coronary CT within 120 days before and after a coronary angiography procedure.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(i) Patients with ischaemic symptoms such as chest pain and no obvious significant stenosis (>50%) on coronary angiography
(ii) Patients who have undergone invasive coronary function assessment (CFR and IMR) using a pressure wire
(iii) Patients who have undergone coronary computed tomography angiography within 120 days before or after coronary angiography
(iv) Patients aged 20 years or over who are eligible for consent
Key exclusion criteria
(i) Patients with >=50% stenosis or occlusive lesion in any of the three branches or side branches with a vessel diameter of >=1.5 mm or fractional flow reserve (FFR) <=0.8 at coronary angiography
(ii) Patients with a history of acute coronary syndrome
(iii) Patients who have undergone revascularisation (percutaneous coronary intervention, coronary artery bypass grafting) in the past
(iv) Patients with suspected hypertrophic cardiomyopathy, cardiac amyloidosis, or Fabry's disease
(v) Patients with moderate or severe valvular disease
(vi) Patients undergoing coronary perfusion assessment after cardiac surgery or percutaneous coronary intervention
(vii) Patients with inadequate quality of coronary computed tomography angiography images and inability to assess PCAT attenuation
(viii) Patients who refused to participate in the study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takayoshi |
| Middle name | |
| Last name | Toba |
Organization
Kobe University Hospital
Division name
Department of Internal Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-5846
taka0222@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Takayoshi |
| Middle name | |
| Last name | Toba |
Organization
Kobe University Hospital
Division name
Department of Internal Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-5846
Homepage URL
taka0222@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Takayoshi Toba
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Kobe University Hospital
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
Tel
078-382-5846
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 | 12 | Month | 01 | 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
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | 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
None
Management information
Registered date
| 2025 | Year | 08 | Month | 02 | Day |
Last modified on
| 2025 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066944
