Tokyo, Dec. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060151) titled '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' on Dec. 22.
Study Type:
Observational
Primary Sponsor:
Institute - Kobe University Graduate School of Medicine
Condition:
Condition - coronary artery disease
Classification by malignancy - Others
Genomic information - NO
Objective:
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
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 Size - 230
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068778
Disclaimer: Curated by HT Syndication.
