A Prospective, Single-site, Single-group Value Study on the Diagnosis of Functional Myocardial Ischemia Based on IVUS Plaque Characteristics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Accuracy of PAV calculated from IVUS images on diagnosing functional myocardial ischemia
研究概览
简要总结
This study aims to evaluate the accuracy of IVUS-calculated percent atheroma volume (PAV) for diagnosing functional myocardial ischemia, using FFR as the gold standard.
详细描述
This prospective, single-site, single-group target-value study aims to investigate the accuracy of intravascular ultrasound (IVUS)-based plaque characteristics in diagnosing functional myocardial ischemia, using coronary fractional flow reserve (FFR) as the gold standard.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study participants must be at least 18 years of age and younger than 80 years of age, regardless of gender;
- •Stable coronary artery disease, unstable angina, or acute myocardial infarction (AMI ≥ 7 days);
- •Coronary angiography showed primary lesions with a visual stenosis of 30% to 90% in at least two coronary arteries ≥ 2.5 mm in diameter;
- •Willing to participate in the study and able to understand, read, and sign the informed consent form.
排除标准
- •STEMI as clinical presentation within 7 days;
- •Chronic Total Occlusion (CTO) as target vessel;
- •Significant contraindication to adenosine administration (e.g., atrioventricular block, severe asthma, etc.);
- •Study participants are currently participating in other drug or device clinical studies and have not achieved the study endpoints;
- •Pregnant or nursing;
- •Other situations considered by the investigator as unsuitable for participation in this study.
结局指标
主要结局
Accuracy of PAV calculated from IVUS images on diagnosing functional myocardial ischemia
时间窗: Intraoperative period（After coronary angiography, before the potential PCI）
Using blood vessels as the research unit and FFR values measured by pressure microcatheters as a reference (FFR ≤ 0.80 is positive, FFR\>0.8 is negative), evaluate the accuracy of PAV calculated from IVUS images on diagnosing functional myocardial ischemia PAV ≥ 39.0% is positive, PAV \< 39.0% is negative).
Sensitivity and specificity of PAV calculated from IVUS images on diagnosing functional myocardial ischemia
时间窗: Intraoperative period（After coronary angiography, before the potential PCI）
Using blood vessels as the research unit and FFR values measured by pressure microcatheters as a reference (FFR ≤ 0.80 is positive, FFR\>0.8 is negative), evaluate the sensitivity and specificity of PAV calculated from IVUS images on diagnosing functional myocardial ischemia (PAV ≥ 39.0% is positive, PAV \< 39.0% is negative).
次要结局
- The positive predictive value, negative predictive value, Receiver Operating Characteristic Curve (ROC) and Area Under the Curve (AUC) of PAV calculated from IVUS images on the diagnosis of functional myocardial ischemia.(Intraoperative period（After coronary angiography, before the potential PCI）)
- Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Total Atheroma Volume (TAV) calculated from IVUS images on the diagnosis of functional myocardial ischemia(Intraoperative period（After coronary angiography, before the potential PCI）)
- Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Minimum Lumen Area (MLA) calculated from IVUS images on the diagnosis of functional myocardial ischemia(Intraoperative period（After coronary angiography, before the potential PCI）)
- Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Plaque Burden (PB) calculated from IVUS images on the diagnosis of functional myocardial ischemia(Intraoperative period（After coronary angiography, before the potential PCI）)
- Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of Diameter Stenosis (DS%) calculated by Quantitative Coronary Angiography (QCA) on diagnosing functional myocardial ischemia(Intraoperative period（After coronary angiography, before the potential PCI）)
- Correlation between PAV, TAV, MLA, PB, DS% and FFR in pairwise comparisons(Intraoperative period（After coronary angiography, before the potential PCI）)
- Correlation between PAV gradient calculated from IVUS images and FFR Pullback Pressure Gradient (PPG)(Intraoperative period（After coronary angiography, before the potential PCI）)