UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060151 |
|---|---|
| Receipt number | R000068778 |
| Scientific Title | Impact of High-Density Lipoprotein Cholesterol Uptake Capacity on the Presence of Unstable Plaques in Culprit Lesions and Post-Procedural Outcomes in Patients Undergoing Percutaneous Coronary Intervention |
| Date of disclosure of the study information | 2025/12/22 |
| Last modified on | 2025/12/21 14:53:58 |
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Basic information
Public title
Impact of High-Density Lipoprotein Cholesterol Uptake Capacity on the Presence of Unstable Plaques in Culprit Lesions and Post-Procedural Outcomes in Patients Undergoing Percutaneous Coronary Intervention
Acronym
Impact of High-Density Lipoprotein Cholesterol Uptake Capacity on the Presence of Unstable Plaques in Culprit Lesions and Post-Procedural Outcomes in Patients Undergoing Percutaneous Coronary Intervention
Scientific Title
Impact of High-Density Lipoprotein Cholesterol Uptake Capacity on the Presence of Unstable Plaques in Culprit Lesions and Post-Procedural Outcomes in Patients Undergoing Percutaneous Coronary Intervention
Scientific Title:Acronym
Impact of High-Density Lipoprotein Cholesterol Uptake Capacity on the Presence of Unstable Plaques in Culprit Lesions and Post-Procedural Outcomes in Patients Undergoing Percutaneous Coronary Intervention
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate the association between cholesterol uptake capacity (CUC), a functional metric of high-density lipoprotein cholesterol, and the prevalence of thin-cap fibroatheroma (TCFA) in culprit lesions among patients undergoing percutaneous coronary intervention (PCI). In addition, we examined the relationship between CUC and clinical outcomes after PCI.
Basic objectives2
Others
Basic objectives -Others
To investigate the usefulness of CUC in predicting plaque instability at culprit lesions in patients with coronary artery disease and in predicting clinical outcomes after PCI.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between TCFA Prevalence and Cholesterol Uptake Capacity
Key secondary outcomes
Relationship between Post-PCI Major Cardiovascular Outcomes and Cholesterol Uptake Capacity
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with coronary artery disease who underwent PCI with OCT at Kobe University Hospital between December 1, 2014, and August 31, 2022, and in whom CUC could be measured using stored frozen blood samples were included. Eligible patients were those who met all of the following inclusion criteria and none of the exclusion criteria.
Inclusion criteria:
1. Patients with coronary artery disease who underwent PCI using OCT.
2. Patients from whom blood samples were collected during the hospitalization for PCI and in whom CUC could be measured using these samples.
3. Patients whose clinical information, including details of medical care, could be obtained from medical records.
4. Patients aged 20 years or older at the time of PCI.
Key exclusion criteria
1. Patients who underwent PCI for in-stent restenosis or stent occlusion.
2. Patients receiving maintenance hemodialysis at the time of PCI.
3. Patients who underwent balloon dilation with a diameter greater than 2.0 mm or atherectomy using a rotablator before OCT imaging.
4. Patients in whom OCT analysis was considered difficult due to insufficient image quality.
5. Patients who requested not to participate in this study based on publicly disclosed information.
6. Any other patients deemed inappropriate for inclusion by the principal investigator.
Target sample size
230
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Otake |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5111
hotake@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Higuchi |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5111
Homepage URL
kh930108@gmail.com
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
non
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
Medical Ethics Committee, Research Ethics Division, Clinical Research Promotion Center, Kobe University Hospital
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel
078-382-5111
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 | 22 | 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
234
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
Completed
Date of protocol fixation
| 2025 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following existing information will be collected: patient baseline characteristics, blood test results obtained from medical records, blood test results, CUC, PCI-related information, clinical outcomes after PCI, and OCT analysis.
Management information
Registered date
| 2025 | Year | 12 | Month | 21 | Day |
Last modified on
| 2025 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068778
