Ignite Creation Date:
2024-05-06 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05029661
Status:
UNKNOWN
Last Update Posted:
2022-04-19
First Post:
2021-08-19
Brief Title:
Ultrasound Elastography for Individual Carotid Plaque Stratification
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Ultrafast Ultrasonic COMpound Push Wave imAging and Strain eStimation Ultra-COMPASS for Individual Plaque Stratification in the Carotid Arteries
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Ultra-COMPASS
Brief Summary:
Ischemic strokes are a leading cause of death and disability worldwide In 20 of cases they are caused by the rupture of atherosclerotic plaques in carotid arteries Risk estimation of plaque rupture is currently suboptimal Although pathology studies have shown that plaque composition provides a better risk assessment lipid-rich core with thin fibrous cap high risk unstable plaque fibrous core and a thick fibrous cap low risk stable plaque plaque composition cannot be determined using imaging techniques and can therefore not be assessed non-invasively Ultrasound which is already widely used in clinical practice to determine plaque geometry could be an optimal technique to determine plaque composition and monitor plaques in a large population due to its low patient burden relatively low cost and speed of measurement However using conventional ultrasound it is not possible to reliably determine plaque composition However this might be possible using newly developed ultrasound functionalitiesshear wave and strain elastography enabling tissue stiffness estimation It is known that recurrence risk is greatest in the first week after a stroke or transient ischemic attack TIA and decreases afterwards probably due to a stabilization of the plaque due to a change in composition Additionally lipid-lowering medication is known to further reduce the recurrence risk after such an event probably due to an acceleration of the stabilization process of the plaque In this study the investigators want to investigate whether Ultra-COMPASS ultrasound measurements a combination of shear wave and strain elastography and ultrafast compounding a fast variant of standard anatomical ultrasound to determine plaque geometry could be used to determine changes in plaque composition after a stroke TIA
Primary objective
Investigate whether it is possible to detect plaque stabilization determined by plaque stiffness after a brain infarction or transient ischemic attack with Ultra-COMPASS ultrasound measurements
Secundary objectives
Determine the association between changes in Ultra-COMPASS measurements and the lipid-lowering drugs used 6 and 12 weeks after ischemic stroke
Determine the association between Ultra-COMPASS measurements and recurrent cardiovascular events TIA cerebral infarction myocardial infarctiondeath 6 and 12 weeks after ischemic stroke
Determine the association between Ultra-COMPASS measurements and changes in low-density lipoprotein levels 6 and 12 weeks after ischemic stroke if known
Study design
This is a prospective longitudinal observational single-center cohort study in patients after a cerebral infarction or TIA with stenosis of one both carotid arteries of 30-70 that receive or start withcholesterol-lowering medication Ultra-COMPASS measurements will be taken within 7 days after brain infarctionTIA and at 6 1 and after 12 1 weeks in both carotid arteries to see if plaques stabilize overtime and to what extent medication stimulates a beneficial change in plaque composition
Primary objective
Investigate whether it is possible to detect plaque stabilization determined by plaque stiffness after a brain infarction or transient ischemic attack with Ultra-COMPASS ultrasound measurements
Secundary objectives
Determine the association between changes in Ultra-COMPASS measurements and the lipid-lowering drugs used 6 and 12 weeks after ischemic stroke
Determine the association between Ultra-COMPASS measurements and recurrent cardiovascular events TIA cerebral infarction myocardial infarctiondeath 6 and 12 weeks after ischemic stroke
Determine the association between Ultra-COMPASS measurements and changes in low-density lipoprotein levels 6 and 12 weeks after ischemic stroke if known
Study design
This is a prospective longitudinal observational single-center cohort study in patients after a cerebral infarction or TIA with stenosis of one both carotid arteries of 30-70 that receive or start withcholesterol-lowering medication Ultra-COMPASS measurements will be taken within 7 days after brain infarctionTIA and at 6 1 and after 12 1 weeks in both carotid arteries to see if plaques stabilize overtime and to what extent medication stimulates a beneficial change in plaque composition
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None