Application of New Algorithm ISR-Net in Measuring CT-FFR of Coronary In-stent Stenosis.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To predict the sensitivity, specificity and accuracy of CT-FFR in the functional sense of in stent lesions based on ISR-Net algorithm.
研究概览
简要总结
CT-FFR(CT-derived flow reserve fraction) usually could not been measured accurately for in-stent lesions due to the serious interference with the metal structs. ISR-Net is a new algorithm in assessing the flow of coronary in-stent stenosis. We compare the CT-FFR value of in-stent lesions with the invasive FFR measured by pressure wire to evaluate the accuracy of ISR-Net algorithm. The research results are of great significance to solve the bottleneck problem of CT-FFR and expand its application scope.
详细描述
CT-FFR is an important noninvasive examination to evaluate the function of coronary artery disease. It can help clinicians make clinical decisions and reduce patients' invasive coronary angiography (ICA). The image quality of coronary CT angiography (CCTA) is the basis of CT-FFR measurement. Because metal stents seriously interfere with the imaging of CCTA, it is very difficult to measure the CT-FFR value of lesions in stents. However, a large number of patients need imaging follow-up evaluation after stenting. In the previous research, the investigators creatively invented a new algorithm ISR-Net and conducted a retrospective analysis. It is preliminarily proved that the algorithm can more accurately display the stenosis lesions in the stent than the previous imaging software, making it possible to calculate the CT-FFR of the lesions in the stent. At present, the algorithm has applied for a national invention patent. In order to transform to clinical application, further clinical verification is needed. This study will evaluate the accuracy of ISR-Net algorithm in assessing the function of coronary stent stenosis by carrying out prospective clinical trials and taking the blood flow reserve fraction (FFR) measured by pressure wire as the gold standard. At the same time, the standard process of CT-FFR measurement of in stent lesions was established. The research results are of great significance to solve the bottleneck problem of CT-FFR and expand its application scope.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria:
- •Over 18 years old;
- •Be able to understand the purpose of the test and sign the informed consent form;
- •Previous intracoronary stent implantation;
- •According to the comprehensive clinical evaluation, coronary angiography and FFR were proposed;
- •CTA image Inclusion Criteria:
- •The coronary CT angiography images showed that the reference vessel diameter of the stenosis segment in the stent was ≥ 2mm;
- •The stenosis degree of coronary stent diameter ≥ 30% and ≤ 90% by visual inspection.
排除标准
- •General exclusion criteria:
- •Previous coronary artery bypass grafting (CABG), artificial heart valve implantation, pacemaker or implantable defibrillator implantation;
- •There are persistent or active symptoms of clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure state (systolic blood pressure less than 90 mmHg), severe congestive heart failure (NYHA cardiac function grade III or IV) or acute pulmonary edema;
- •Acute myocardial infarction occurred within 7 days before enrollment;
- •Patients with other severe diseases are not suitable for clinical trials, such as complex congenital heart history, sick sinus syndrome, long QT syndrome, severe arrhythmia or tachycardia, severe asthma, severe or very severe chronic obstructive pulmonary disease, chronic renal function impairment (serum creatinine value > 1.5 mg / dL or creatinine clearance rate < 45ml / kg · 1.73m2);
- •There are contraindications to the use of disodium adenosine triphosphate;
- •Allergic to iodized contrast media;
- •Pregnancy or unknown pregnancy status;
- •The expected life is less than 2 months;
- •There are any other factors that the researchers believe are not suitable for inclusion or completion of this study.
- •CTA image exclusion criteria:
- •The coronary artery image was obviously misplaced;
- •Coronary artery occlusion.
结局指标
主要结局
To predict the sensitivity, specificity and accuracy of CT-FFR in the functional sense of in stent lesions based on ISR-Net algorithm.
时间窗: one month
次要结局
- To predict the functional accuracy of in stent lesions, PPV, NPV and area under ROC curve (AUC)(one month)
研究者
Xue Yu
project manager
Beijing Hospital