NCT06619353进行中（未招募）不适用
Residual CardioVascular Risk (RCVR) After Percutaneous Coronary Intervention: A Prospective Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Net adverse clinical event
研究概览
简要总结
The goal of this observational study is to evaluate whether residual cardiovascular risk assessed at 1 month after percutaneous coronary intervention (PCI) is associated with long-term clinical outcomes in adult patients with coronary artery disease who are free from major adverse clinical events at 1 month after PCI. The main questions it aims to answer are:
- Does residual cardiovascular risk at 1 month after PCI predict long-term net adverse clinical events?
- Which components of residual cardiovascular risk are associated with subsequent adverse clinical outcomes?
Participants will:
- Undergo comprehensive laboratory testing at 1 month after PCI and annually thereafter.
- Undergo artificial intelligence-based quantitative coronary angiographic analysis using DICOM datasets after PCI.
- Be followed annually for up to 3 years after the 1-month assessment to evaluate clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have undergone percutaneous coronary intervention.
- •Patients who are free from death, myocardial infarction, stroke, unplanned revascularization, or major bleeding within 1 month after the index PCI.
- •Patients who are able to undergo artificial intelligence-based quantitative coronary angiography using DICOM datasets.
- •Patients who have provided written informed consent at the 1-month post-PCI visit.
排除标准
- •Under 19 years of age.
- •Pregnant, breastfeeding, or women of childbearing age.
- •Currently has a malignancy or has a history of malignancy within the past 5 years.
- •Life expectancy of less than 5 years.
- •Occurrence of death, myocardial infarction, stroke, unplanned revascularization, or major bleeding within 1 month after the index PCI.
- •Inability or unwillingness to comply with scheduled follow-up assessments.
研究组 & 干预措施
Residual CardioVascular Risk
Residual cardiovascular risk is assessed in patients undergoing PCI.
干预措施: Blood Sample (Diagnostic Test)
Residual CardioVascular Risk
Residual cardiovascular risk is assessed in patients undergoing PCI.
干预措施: DICOM Dataset (Other)
结局指标
主要结局
Net adverse clinical event
时间窗: 3 years after the 1-month assessment (baseline)
The composite of cardiovascular death, nonfatal spontaneous (nonprocedural) myocardial infarction, nonfatal ischemic stroke, unplanned hospitalization leading to urgent revascularization, and major bleeding.
次要结局
- Cardiovascular death(3 years after the 1-month assessment (baseline))
- Nonfatal spontaneous (nonprocedural) myocardial infarction(3 years after the 1-month assessment (baseline))
- Nonfatal ischemic stroke(3 years after the 1-month assessment (baseline))
- Unplanned hospitalization leading to urgent revascularization(3 years after the 1-month assessment (baseline))
- Major bleeding(3 years after the 1-month assessment (baseline))
- V-Angiographic success(1 month post-intervention)
- V-Complete revascularization(1 month post-intervention)
- AI-Angiographic success(1 month post-intervention)
- AI-Complete revascularization(1 month post-intervention)
- Platelet reactivity(1 month post-intervention)
- Thrombogenicity profiles(1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline)
- Lipid profiles(1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline)
- Hemoglobin A1C(1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline)
- High-sensitivity C-reactive protein(1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline)
研究者
Seung-Yul Lee
Associate Professor
CHA University
研究点 (1)
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