Assessment of Coronary Artery Disease With Multi-Slice Computed Tomography Combined With Stress Cardiac Magnetic Resonance Imaging Compared to Coronary Angiography Combined With Fractional Flow Reserve Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Diagnostic accuracy to detect ischemia with stress CMR compared to FFR
研究概览
简要总结
The purpose of the study is to assess the diagnostic accuracy of a combined use of non-invasive coronary angiography with multi-slice computed tomography (MSCT) and stress cardiac magnetic resonance (CMR) imaging in patients with obstructive lesions on MSCT and with low to intermediate pre-test likelihood of coronary artery disease (CAD) as compared to invasive coronary angiography (CAG) and Fractional Flow Reserve (FFR) measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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 with stable angina pectoris with low to intermediate pre-test likelihood of CAD;
- •no previous history of CAD;
- •obstructive stenosis (≥50% luminal narrowing) on MSCT coronary angiography; 4.informed consent.
排除标准
- •patients with a previous history of CAD;
- •patients with contraindications for MSCT: a.cardiac rhythms other than sinus rhythm, b.pregnancy, c.allergy for contrast medium, d.renal failure (estimated glomerular filtration rate (eGFR) < 50ml/min), e.resting heart rate >75 bpm plus contra-indications for beta-blockade, f. weight >100 kilograms;
- •contraindications for cardiac magnetic resonance (CMR) imaging: a.MR-incompatible implants, b. Claustrophobia, c. contraindications for adenosine: i. known or suspected hypersensitivity to adenosine, ii. known or suspected bronchoconstrictive or bronchospastic disease, iii. 2nd or 3rd degree atrioventricular (AV) block, iv. Sinus bradycardia (heart rate < 45 bpm), v. Systemic arterial hypotension (<90 mmHg). d. contraindications for gadolinium: i. renal failure (estimated eGFR <30 ml/min);
- •no informed consent.
研究组 & 干预措施
Imaging arm
There is one study arm only. The imaging modalities will be performed in all patients.
干预措施: adenosine stress Cardiac Magnetic Resonance Imaging (Device)
结局指标
主要结局
Diagnostic accuracy to detect ischemia with stress CMR compared to FFR
时间窗: one month
The diagnostic accuracy of MSCT coronary angiography in combination with stress CMR imaging as compared to invasive CAG and FFR measurement, as a standard of reference to detect obstructive and hemodynamically significant stenoses in patients with low to intermediate pre-test likelihood of CAD.
次要结局
- Predictive value for treatment strategy of a non-invasive strategy with MSCT and stress CMR compared to an invasive strategy(one month)
研究者
Gabija Pundziute
Principal Investigator
University Medical Center Groningen