Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
NCT ID:
NCT03335033
Group ID:
EG000
Title:
Carotid Plaques With >70% Stenosis
Description:
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.
Deaths Number Affected:
2
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
17
Other Number Affected:
0
Other Number At Risk:
17
Study:
NCT03335033
Results Section:
NCT03335033
Adverse Events Module:
NCT03335033