Comparison of Cardiovascular Magnetic Resonance and Computed Tomography With Fractional Flow Reserve in the Diagnosis of Suspected Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 1. Diagnostic performance of CMR and CT-FFR
研究概览
简要总结
CONCORD is a prospective observational study evaluating the diagnostic accuracy of cardiovascular magnetic resonance (CMR) and computed tomography with fractional flow reserve (CT-FFR) in patients with suspected coronary artery disease, using invasive fractional flow reserve (FFR) as the reference standard.
详细描述
In patients with suspected coronary artery disease (CAD), CT coronary angiography (CTCA) provides excellent sensitivity and negative predictive value, enabling the safe exclusion of significant CAD. However, its positive predictive value remains suboptimal (c.50%). Undertaking additional CT-FFR improves specificity and positive predictive value, reducing unnecessary invasive coronary angiography. It has been established that CMR perfusion imaging offers excellent diagnostic accuracy for the identification of functionally significant coronary artery disease. The diagnostic performance of qualitative CMR perfusion assessment may be further enhanced by additional quantitative assessment. The purpose of this prospective observational study is to evaluate the diagnostic performance of all three modalities (CT-FFR and qualitative and quantitative CMR perfusion imaging), involving 300 patients with suspected coronary artery disease referred for invasive coronary angiography. A subset of 167 subjects will undergo an additional accelerated CMR scan for comparison. Invasively measured fractional flow reserve (FFR) will serve as the reference 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥18 years
- •Referred for invasive coronary angiography for investigation of chest pain
排除标准
- •Recent acute coronary syndrome (< 6 months)
- •Previous coronary artery bypass grafting
- •Severe claustrophobia
- •Absolute contraindications to CMR - those with MR conditional or safe devices will be included
- •Second-/third-degree atrioventricular block
- •Severe chronic obstructive pulmonary disease
- •Moderate-severe asthma
- •Estimated glomerular filtration rate <30 ml/min/1.73m2
- •Women who are pregnant, breast-feeding or of child-bearing potential( premenopausal women)
- •Contraindication to iodinated contrast
- •Participation in a research study involving an investigational product in the past 12 weeks
结局指标
主要结局
1. Diagnostic performance of CMR and CT-FFR
时间窗: 6 weeks
Diagnostic accuracy of CMR perfusion imaging (quantitative and qualitative analysis) and CT-FFR to determine the presence/absence of significant coronary artery disease at the subject level when compared with invasive FFR.
次要结局
- 2. Diagnostic performance of CMR and CT-FFR(6 weeks)
- 6. Cost analysis(2 years)
- 1. Diagnostic performance of CMR and CT-FFR(6 weeks)
- 3. Diagnostic performance of CMR T1 mapping(6 weeks)
- 4. Diagnostic performance of hybrid imaging(6 weeks)
- Diagnostic performance of strain assessment(6 weeks)
- 7. Clinical endpoints(2 years)
- 8. Subjective experience(1 day)
- 9. Time duration of each scan/scan component.(1 day)
- 10. Image quality(1 day)