Risk Assessment of Carotid Plaques Based on Pressure Estimation Using 3D Contrast-enhanced Ultrasound
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Correlation between the pressure gradient and surrogate (imaging and histological) predictors
研究概览
简要总结
This is an open-label, non-randomized study conducted at Thomas Jefferson University comparing pressure-gradient estimates (obtained between a carotid plaque and the carotid artery) to imaging and histology markers of plaque vulnerability. There is an inverse relationship between the subharmonic signal magnitude from contrast-enhanced ultrasound microbubbles and ambient pressure. This pressure estimation technique (referred as SHAPE) will be used to estimate the pressure gradient across the carotid plaque cap noninvasively in vivo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 >18 years old and willing and able to participate. Patients with atherosclerosis scheduled for carotid endarterectomy
排除标准
- •• Pregnancy or breast-feeding at the time of the scan
- •Patients with known hypersensitivity or allergy to any component (including perflutren) of Definity (Lantheus Medical Imaging, Billerica, MA).
- •Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
- •Patients on life support or in a critical care unit.
- •Patients with unstable occlusive disease (e.g., crescendo angina).
- •Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.
- •Patients with uncontrolled congestive heart failure (NYHA Class IV).
- •Patients with recent cerebral hemorrhage.
- •Patients who have undergone surgery within 24 hours prior to the study sonographic examination.
- •Patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) or respiratory distress syndrome.
- •Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli.
- •Patients who have received any contrast medium (X-ray, MRI, CT or ultrasound) in the 24 hours prior to the research ultrasound exam
结局指标
主要结局
Correlation between the pressure gradient and surrogate (imaging and histological) predictors
时间窗: pre-endarterectomy
The estimates of pressure-gradient across the plaque cap from 3D SHAPE technique will be compared with the surrogate imaging and histological predictors using Pearson's correlation coefficient. The correlations between the surrogate predictors will be also calculated using Pearson's correlation coefficient. We expect the pressure-gradient estimates from SHAPE technique is moderately correlated (above 0.5) with the surrogate predictors.
次要结局
未报告次要终点