VAP-Measured Lipid Subfractions and In-Stent Restenosis After PCI (NCT07533656) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
VAP-Measured Lipid Subfractions and In-Stent Restenosis After PCI
China3,600 participantsStarted 2025-07-01
Plain-language summary
This multicenter observational study investigates whether lipid and lipoprotein subfractions measured by Vertical Auto Profile (VAP) are associated with coronary in-stent restenosis after percutaneous coronary intervention (PCI). The study includes a retrospective cross-sectional component in patients with prior PCI who undergo repeat coronary angiography and a prospective follow-up component in patients undergoing index PCI. Serum samples obtained from routine clinical blood collection will be used for VAP testing without additional blood draws.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Retrospective cross-sectional component:
* Age \>=18 years
* Prior successful implantation of second-generation drug-eluting stents
* Repeat coronary angiography available at a participating center
* Complete data available for ASCVD risk assessment
* Stored serum sample available for VAP testing
* Angiographic data sufficient to determine ISR status
Prospective component:
* Age \>=18 years
* Undergoing index PCI
* Planned routine follow-up coronary angiography
* Complete data available for ASCVD risk assessment
* Serum sample available from routine clinical blood collection
* Able to provide written informed consent and any required privacy authorization
Exclusion Criteria:
* Severe hepatic dysfunction (ALT or AST \>3 x ULN or Child-Pugh class C)
* Prior CABG with angioplasty performed in a non-native vessel
* In-stent restenosis occurring within 1 month after PCI
* Expected survival \<1 year (prospective component)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Presence of angiographic in-stent restenosis in the retrospective cross-sectional cohort
Timeframe: At repeat coronary angiography, more than 6 month after prior PCI
2
Occurrence of angiographic in-stent restenosis in the prospective cohort
Timeframe: At follow-up coronary angiography, up to 12 months after index PCI
3
Target lesion revascularization in the prospective cohort
Timeframe: Within 12 months after index PCI
Trial details
NCT IDNCT07533656
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University