UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054809 |
|---|---|
| Receipt number | R000062509 |
| Scientific Title | Non-invasive identification of high-risk plaques in non-culprit lesions of acute coronary syndrome |
| Date of disclosure of the study information | 2024/06/30 |
| Last modified on | 2024/06/28 15:32:10 |
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Basic information
Public title
Non-invasive identification of high-risk plaques in non-culprit lesions of acute coronary syndrome
Acronym
Non-invasive identification of high-risk plaques in non-culprit lesions of acute coronary syndrome
Scientific Title
Non-invasive identification of high-risk plaques in non-culprit lesions of acute coronary syndrome
Scientific Title:Acronym
Non-invasive identification of high-risk plaques in non-culprit lesions of acute coronary syndrome
Region
| Japan |
Condition
Condition
acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of the study was to determine whether delta-FFR-CT and Coronary computed tomographic angiography(CCTA) measurements could more easily differentiate lesions with maxLCBI4mm greater than 400 by near-infrared spectroscopy intravascular ultrasound (NIRS-IVUS) in non-culprit lesions of ACS.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between maxLCBI4mm values as indicated by NIRS-IVUS and plaque density,remodeling index, presence of microcalcification and napkin ring sign as assessed by CCTA and difference between FFR-CT proximal and distal to the stenosis (delta-FFR-CT) in non-responsive lesions
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) patients were admitted with ACS (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, and unstable angina pectoris); (2) intermediate stenosis in non-culprit lesions on coronary angiography or CCTA; (3) NIRS-IVUS evaluation for intermediate stenosis after percutaneous coronary intervention; and (4) each non-culprit lesion was evaluated using CCTA and FFRCT performed within a duration of 14 days between CT and percutaneous coronary intervention.
Key exclusion criteria
(1) chronic kidney disease as shown by an estimated glomerular filtration rate <30 ml/min/1.73 m2; (2) presentation with hemodynamic instability; (3) severe valvular heart diseases, (4) left main trunk lesions; (5) lesions that could not be evaluated by NIRS-IVUS for any reason (e.g., tortuous vessels, severe stenosis, and calcification that made catheter passage difficult); and (6) poor image quality that resulted in an inability to perform CCTA or NIRS-IVUS analysis.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Ueno |
Organization
Kindai University Faculty of Medicine
Division name
Division of Cardiology
Zip code
589-8511
Address
377-2, Ohno-Higashi, Osakasayama, Osaka, Japan
TEL
81-72-366-0221
mueno@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Kakehi |
Organization
Kindai University Faculty of Medicine
Division name
Division of Cardiology
Zip code
589-8511
Address
377-2, Ohno-Higashi, Osakasayama, Osaka, Japan
TEL
81-72-366-0221
Homepage URL
kakehi324@yahoo.co.jp
Sponsor or person
Institute
Kindai University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kindai University Faculty of Medicine
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
Kindai University Faculty of Medicine
Address
377-2, Ohno-Higashi, Osakasayama, Osaka, Japan
Tel
81-72-366-0221
kakehi324@yahoo.co.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
| 2024 | Year | 06 | Month | 30 | 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
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After the protocol has been approved by the Director, case enrollment will begin until December 2025 (the period of accumulation may be changed depending on the status of case enrollment). The study period, including the follow-up period, will be until the end of December 2026.
Management information
Registered date
| 2024 | Year | 06 | Month | 28 | Day |
Last modified on
| 2024 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062509
