The Detection of Coronary Stenosis With Intravenous Mircrobubbles and Contrast Pulse Sequence Low Mechanical Index Imaging
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Detection of coronary and carotid artery stenoses and perfusion defects during standard echocardiographic examination
研究概览
简要总结
To detect coronary artery disease by both coronary and carotid artery imaging and myocardial perfusion imaging using a new low mechanical index real time system.
详细描述
The objective of this clinical study will be to visualize both coronary and carotid arteries as well as detect myocardial perfusion following a routine intravenous injection of Definity (0.05-0.20 millimeters), Optison (0.1-0.4 millimeters) or PESDA (0.05-0.2 mL). Following these injections , we will attempt to Contrast Pulse Sequencing on the Siemens Acuson Sequoia system to image both the coronary and carotid arteries, as well as the Myocardial perfusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects scheduled for routine echocardiogram to look for evidence of Coronary artery disease or a stress echocardiogram
- •women of child-bearing potential must be taking a medically approved form of birth control with a negative urine pregnancy test
- •be conscious and coherent, and be able to communicate effectively with study personnel
- •last eight patients will be diabetics who smoke
- •provide informed consent after receiving a verbal and written explanation of the purpose and nature of the study
排除标准
- •severe valvular heart disease by Doppler Echocardiography
- •females of child-bearing potential who are not taking a medically approved method of birth control will be excluded. If the patient is pregnant she will be excluded.
- •patients who are allergic to blood or blood products will be excluded
- •have contraindication to Optison, Definity, or PESDA (pulmonary HTN, cardiac shunt)
- •non diabetics, non smokers
研究组 & 干预措施
1 Intravenous Optison Followed by Contrast Pulse Sequencing
Administration of Optison (0.1-0.4 mL) intravenously followed by Contrast Pulse Sequencing to image both the coronary and carotid arteries.
Use will depend on availability of the contrast for the given study Optison will not be used on patients with blood allergies or Jehovah Witnesses
干预措施: Optison (Drug)
2 Intravenous Definity followed by Contrast Pulse Sequencing
Intravenous injection of Definity (0.05-0.20 mL) followed by Contrast Pulse Sequencing to image both coronary and carotid arteries
干预措施: Definity (Drug)
3 Intravenous PESDA followed by Contrast Pulse Sequencing
Intravenous injection of PESDA at a rate of 0.05-0.20 mL followed by Contrast Pulse Sequencing image of coronary and carotid arteries PESDA will be used exclusively in patients who are eligible for other IRB studies
干预措施: PESDA (Drug)
结局指标
主要结局
Detection of coronary and carotid artery stenoses and perfusion defects during standard echocardiographic examination
时间窗: 2-4 months
To determine whether this imaging scheme can detect both coronary and carotid artery stenoses as well as perfusion defects during a standard echocardiographic examination
次要结局
- Visual analysis of coronary and carotid arteries and perfusion defects during standard echocardiogram examination(immediate)