Diagnostic Accuracy of CCTA-derived Versus AngiogRaphy-dErived QuantitativE Flow Ratio Study
试验速览
- 阶段
- 不适用
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Diagnostic performance of CT-QFR
研究概览
简要总结
To perform CT-QFR, invasive coronary angiography, FFR, and QFR tests on patients with moderate coronary stenosis after coronary CTA examination. Use FFR as a reference to verify the diagnostic performance of CT-QFR, and compare it with QFR.
详细描述
This study is a prospective and single-center trial in China.It intends to enroll 216 patients with coronary artery disease whose coronary artery is determined to be 30-90% stenosis after coronary CT scan. CT image data will be imported for CT-QFR detection and undergo coronary angiography within 30 days. Quantitative analysis of coronary angiography (QCA) was performed with the degree of coronary stenosis. FFR and QFR were detected during the operation. Use FFR as a reference standard to verify the diagnostic performance of CT-QFR and QFR. The primary endpoint is the diagnostic accuracy of CT-QFR in identifying hemodynamically significant coronary stenosis with FFR as the reference standard. Major secondary endpoint is the non-inferiority of CT-QFR compared with QFR in the patients without extensively calcified lesions. The completion of the project will provide patients with a practical non-invasive assessment method of coronary heart disease which provides the best treatment strategy.
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
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary CT angiography indicates that >= 1 stenosis with percent diameter stenosis between 30%-90% in a vessel >= 2mm.
- •The invasive coronary angiography should be less than 30 days after the coronary CT angiography.
排除标准
- •The target lesion has received coronary stent implantation or coronary artery bypass graft.
- •Target lesion involves myocardial bridge.
- •Severe heart failure (NYHA ≥III).
- •Renal function is seriously damaged (eGFR<30 ml/min/1.73m2).
- •Those who are contraindicated to use contrast agents, beta blockers, nitrates or adenosine drugs.
- •Acute myocardial infarction within 1 month.
- •The image quality of CTA or coronary angiography cannot be assessed.
- •Any factors that affect the image quality of coronary CTA and coronary angiography, such as frequent premature contractions, atrial fibrillation, etc.
结局指标
主要结局
Diagnostic performance of CT-QFR
时间窗: 1.5 year
Diagnostic accuracy of on-site CT-QFR in identifying physiologically significant coronary artery stenosis, using FFR as the reference standard. Presence of hemodynamically-significant coronary artery stenosis : FFR \<= 0.80.
次要结局
- Correlation between CT-QFR and FFR(1.5 year)
- Other common measures of diagnostic performance of CT-QFR(1.5 year)
- Comparision between CT-QFR and QFR(1.5 year)
- The comparison between CT-QFR, CCTA-derived percent diameter stenosis (CTA-DS%) and QCA-derived DS%(1.5 year)
研究者
Zhijun Bao
Huadong Hospital, Department of Cardiology
Fudan University