Carotid Atherosclerosis
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTPerflutren
The ultrasound contrast agent is used to improve the quality of ultrasound imaging and is infused over 5-10 minutes. The contrast agent consists of the gas-filled microbubbles smaller than the capillary size which circulate in the vascular system. The contrast agent is cleared from the body naturally within 30 minutes.
Sponsors
Thomas Jefferson University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \>18 years old and willing and able to participate. Patients with atherosclerosis scheduled for carotid endarterectomy
Exclusion criteria
* • 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between the pressure gradient and surrogate (imaging and histological) predictors | 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. |
Countries
United States
Outcome results
None listed