Trial Outcomes & Findings for New Technologies to Determine Carotid Plaque Vulnerability in Patients With Significant Carotid Plaques (NCT NCT03335033)

Subjects who had a plaque causing a \> 70% stenosis were approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound. Contrast-enhanced ultrasound: Subjects received a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also, use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected. Shear Wave Elastography: Shear wave elastography as performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes. Ultrasound Examination: A standard carotid US examination using Duplex imaging was performed using a linear array transducer to obtain longitudinal and transverse images. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.

Subjects with moderate (50-69% diameter) stenosis carotid plaques were approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound. Contrast-enhanced ultrasound: Subjects received a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also, use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected. Shear Wave Elastography: Shear wave elastography as performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes. Ultrasound Examination: A standard carotid US examination using Duplex imaging was performed using a linear array transducer to obtain longitudinal and transverse images. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.

n=17 Participants

Subjects who had a plaque causing a \> 70% stenosis were approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound. Contrast-enhanced ultrasound: Subjects received a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also, use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected. Shear Wave Elastography: Shear wave elastography as performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes. Ultrasound Examination: A standard carotid US examination using Duplex imaging was performed using a linear array transducer to obtain longitudinal and transverse images. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.

n=37 Participants

Subjects with moderate (50-69% diameter) stenosis carotid plaques were approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound. Contrast-enhanced ultrasound: Subjects received a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also, use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected. Shear Wave Elastography: Shear wave elastography as performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes. Ultrasound Examination: A standard carotid US examination using Duplex imaging was performed using a linear array transducer to obtain longitudinal and transverse images. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.

n=54 Participants

Total of all reporting groups

n=17 Participants

Subjects who had a plaque causing a \> 70% stenosis were approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound. Contrast-enhanced ultrasound: Subjects received a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also, use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected. Shear Wave Elastography: Shear wave elastography as performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes. Ultrasound Examination: A standard carotid US examination using Duplex imaging was performed using a linear array transducer to obtain longitudinal and transverse images. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.

n=37 Participants

Subjects with moderate (50-69% diameter) stenosis carotid plaques were approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound. Contrast-enhanced ultrasound: Subjects received a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also, use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected. Shear Wave Elastography: Shear wave elastography as performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes. Ultrasound Examination: A standard carotid US examination using Duplex imaging was performed using a linear array transducer to obtain longitudinal and transverse images. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.