Diagnostic Value of a Rapid Protocol Regadenoson Stress Cardiovascular Magnetic Resonance Scan for Detection of Coronary Artery Disease
试验速览
- 阶段
- 4 期
- 发起方
- Dipan Shah
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Profile of sensitivity, specificity, and diagnostic accuracy of rapid regadenoson stress CMR.
研究概览
简要总结
This study is designed to evaluate the feasibility and diagnostic performance of a novel rapid regadenoson stress CMR protocol for detecting of obstructive coronary artery disease.
详细描述
This is a single center, open-label, pilot study in subjects scheduled for invasive coronary angiography for evaluation of coronary artery disease. The primary objective is to evaluate the profile of sensitivity, specificity, and diagnostic accuracy of a novel rapid regadenoson stress CMR protocol for detection of >= 70 coronary artery stenosis on invasive coronary angiography. Additionally the objective will be to compare the time for performance of this novel rapid regadenoson stress CMR protocol in comparison to the standard stress CMR protocol.
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
- •Aged 18 years or older
- •Scheduled for invasive coronary angiography
排除标准
- •Inability to give informed consent
- •Possible pregnancy (confirmed by urine test)
- •Women who are breastfeeding
- •Severe claustrophobia
- •Inability to lie flat for 20-30 minutes (the anticipated amount of time to complete the MRI procedure)
- •Individuals with cochlear implants
- •Individuals with non-MRI compatible aneurysm clips
- •Potential contraindications to regadenoson use due to:
- •Severe lung disease (active wheezing) Severe bradycardia (heart rate < 40 beats/min) Second- or third-degree atrioventricular heart block Sick sinus syndrome History of Long QT syndrome Severe hypotension (systolic BP < 80 mm Hg) Decompensated heart failure
- •Contraindication to administration of Gadolinium (Gd) based contrast agents (GBCA):
- •Stage 4 or 5 chronic kidney disease (eGFR < 30 ml/min/1.73 m2) Known allergy to GBCA
- •Special Considerations:
- •Although individuals who have an occupational history of welding, grinding, or other metal work will not be excluded from the study, they must undergo an orbital x-ray, to exclude any occult metal fragments, before they can participate in this study.
研究组 & 干预措施
single-arm
Additional images collected during routine cardiac MRI (CMR) with diagnostic imaging agent, regadenoson.
干预措施: regadenoson (Drug)
结局指标
主要结局
Profile of sensitivity, specificity, and diagnostic accuracy of rapid regadenoson stress CMR.
时间窗: Up to 7 days
Evaluate the profile of sensitivity, specificity, and diagnostic accuracy of a rapid regadenoson stress CMR protocol for the detection of \>= 70% stenosis of a major epicardial coronary artery on invasive coronary angiography.
次要结局
- Evaluate time for performance of rapid regadenoson stress CMR protocol.(Up to 7 days)
研究者
Dipan Shah
Director, Cardiac Magnetic Resonance Imaging
The Methodist Hospital Research Institute