Study Examining if Sonazoid is an Effective Contrast Agent to Identify Myocardial Perfusion
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To demonstrate if sonazoid gives adequate opacification of the myocardium at intermediate mechanical index using stress echocardiography
研究概览
简要总结
Currently, Sonazoid is mainly used for imaging liver lesions by assessing perfusion characteristics. However, the ultrasound technology is the same as for cardiac imaging and the stability of the microbubbles will potentially aid the detection of myocardial perfusion defects. This study will look at the feasibility of using sonozoid in this way.
详细描述
Ultrasound contrast agents are gas-filled microbubbles that enhance the visualisation of cardiac structures, function and blood flow. Myocardial contrast echocardiography enables us to visualise myocardial perfusion and provides incremental information for diagnosis of coronary artery disease (CAD) and prognosis beyond wall motion assessment .
Using ultrasound at low acoustic power (low/intermediate MI) causes the microbubbles to oscillate resulting in giving off non-linear signals which are different from tissues which gives off linear signals.
The first contrast agents were used in 1968. Since then the technology has been refined and now the microbubbles are more stable and consist of an inert gas encapsulated in a lipid or albumin shell. These microbubbles remain intact in the systemic circulation because of their small size can transit through the pulmonary circulation.
The indication for myocardial perfusion imaging is when vasodilator stress like Dipyridamole is performed. Vasodilators do not readily induce wall motion abnormalities but cause perfusion defects to occur which allows detection of CAD. Myocardial perfusion imaging is also indicated during treadmill or dobutamine stress when suspicion of CAD is high as it is more sensitive than wall motion for the detection of CAD.
Myocardial perfusion imaging looks at a uniformity of contrast appearance in the myocardium, following a continuous microbubble infusion. If there is decreased perfusion, the appearance of contrast will be delayed and the opacification will not be uniform.
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
- •Positive and normal Clinical SE
- •Able to provide informed consent
排除标准
- •Unable / unwilling to give informed consent
- •Allergy to Perfluorobutane
- •Egg allergy
- •Patients with right to left arteriovenous cardiac or pulmonary shunt
- •Unstable heart disease
- •Serious pulmonary disease
- •Pregnancy or lactation Women of child bearing potential (defined as not chemically or surgically sterilised or post menopausal)
结局指标
主要结局
To demonstrate if sonazoid gives adequate opacification of the myocardium at intermediate mechanical index using stress echocardiography
时间窗: 1 day
Contrast Stress echocardiography (SE) using sonazoid will be used to predict if patients with very low probability of CAD have flow-limiting coronary stenosis\>70% in any major coronary artery branches in patients with previous significant (\>2 contiguous segments) inducible ischemia on stress echocardiography (SE).
To demonstrate if sonazoid gives adequate opacification of the myocardium at low mechanical index using stress echocardiography
时间窗: 1 day
Contrast Stress echocardiography (SE) using sonazoid will be used to predict if patients with very low probability of CAD have flow-limiting coronary stenosis\>70% in any major coronary artery branches in patients with previous significant (\>2 contiguous segments) inducible ischemia on stress echocardiography (SE).
次要结局
- Myocardial blood flow reserve assessment for prediction of flow-limiting CAD(1 day)