UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058107 |
|---|---|
| Receipt number | R000066415 |
| Scientific Title | Prognostic Significance of Pericoronary Fat Attenuation Index in Cardiovascular Disease: A Systematic Review and Meta-Analysis |
| Date of disclosure of the study information | 2025/06/06 |
| Last modified on | 2025/06/06 16:09:45 |
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Basic information
Public title
Prognostic Significance of Pericoronary Fat Attenuation Index in Cardiovascular Disease: A Systematic Review and Meta-Analysis
Acronym
Prognostic Significance of Pericoronary Fat Attenuation Index in Cardiovascular Disease: A Systematic Review and Meta-Analysis
Scientific Title
Prognostic Significance of Pericoronary Fat Attenuation Index in Cardiovascular Disease: A Systematic Review and Meta-Analysis
Scientific Title:Acronym
Prognostic Significance of Pericoronary Fat Attenuation Index in Cardiovascular Disease: A Systematic Review and Meta-Analysis
Region
| Japan |
Condition
Condition
The target diseases will include a broad spectrum of cardiovascular diseases, primarily focusing on coronary artery disease. This includes stable angina, unstable angina, myocardial infarction, and heart failure.
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study will be to investigate whether the pericoronary fat attenuation index (FAI), as measured by coronary computed tomography angiography (CCTA), serves as a useful prognostic marker in cardiovascular disease. Specifically, we will conduct a systematic review and meta-analysis to evaluate the association between FAI and adverse cardiovascular outcomes, including major adverse cardiovascular events (MACE) and cardiac mortality.
Basic objectives2
Others
Basic objectives -Others
meta-analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The pericoronary fat attenuation index (FAI), derived from coronary computed tomography angiography (CCTA), is a noninvasive imaging biomarker that reflects inflammation-induced changes in perivascular adipose tissue (PVAT); this study aims to evaluate the prognostic value of FAI for major adverse cardiovascular events (MACE), cardiac mortality, and all-cause mortality, with subgroup analyses based on coronary artery (right coronary artery [RCA], left anterior descending artery [LAD], and left circumflex artery [LCX]) and geographic region (Asian vs. non-Asian populations).
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion Criteria:
Original studies reporting hazard ratios (HRs) for major adverse cardiovascular events (MACE), cardiac mortality, or all-cause mortality in relation to pericoronary fat attenuation index (FAI) measured by coronary computed tomography angiography (CCTA)
Clear documentation of the coronary artery segment analyzed (right coronary artery [RCA], left anterior descending artery [LAD], or left circumflex artery [LCX])
Human studies
Articles published in English
Key exclusion criteria
Exclusion Criteria:
Studies not reporting prognostic outcomes (MACE, cardiac mortality, or all-cause mortality)
Review articles, case reports, and non-human studies
Non-English language articles
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Department of Diagnostic Radiology, Yokohama City University
Division name
Department of Diagnostic Radiology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawaku, Yokohama
TEL
045-787-2800
shingo.m12226@gmail.com
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Yokohama City University Hospital
Division name
Department of Diagnostic Radiology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawaku, Yokohama
TEL
045-787-2800
Homepage URL
shingo.m12226@gmail.com
Sponsor or person
Institute
Shingo Kato, Department of Diagnostic Radiology, Yokohama City University
Institute
Department
Personal name
Shingo Kato
Funding Source
Organization
Department of Diagnostic Radiology, Yokohama City University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University
Address
3-9, Fukuura, Kanazawaku, Yokohama
Tel
045-787-2800
shingo.m12226@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Japan
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a planned systematic review and meta-analysis aiming to evaluate whether the pericoronary fat attenuation index (FAI), derived from coronary computed tomography angiography (CCTA), serves as a prognostic marker for major adverse cardiovascular events (MACE), cardiac mortality, and all-cause mortality. The meta-analysis will include observational studies, and data extraction is currently underway following predefined eligibility criteria. A quantitative synthesis will be performed subsequently.
Management information
Registered date
| 2025 | Year | 06 | Month | 06 | Day |
Last modified on
| 2025 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066415
