Ultrasound Elastography for Individual Carotid Plaque Stratification (Ultra-COMPASS)

April 12, 2022 updated by: Radboud University Medical Center

Ultrafast Ultrasonic COMpound Push Wave imAging and Strain eStimation (Ultra-COMPASS) for Individual Plaque Stratification in the Carotid Arteries

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 functionalities(shear 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 infarction/death) 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 infarction/TIA 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with a transient ischemic attack (diffusion restriction on DWI/ADC sequences of the cerebral MRI, corresponding to recent ischemia) or brain infarction and a carotid atherosclerotic plaque with a stenosis of 30-70% of (one of both) carotid arteries that receive or start with lipid-lowering drugs

Description

Inclusion Criteria:

  • Transient ischemic attack in anterior flow area (with diffusion restriction on DWI/ADC sequences of the cerebral MRI, corresponding to recent ischemia) or clinical diagnosis of brain infarction (cerebral CT for exclusion of brain haemorrhage)
  • Opportunity to undergo Ultra-COMPASS ultrasound measurements ≤7 days after initiation of first clinical symptoms
  • Stenosis 30-70% of carotid arteries based on clinically performed carotid ultrasound or thickening of at least 2mm on CT/MR scan
  • ≥18 jaar
  • Signed informed consent

Exclusion Criteria:

  • Total occlusion common carotid artery or internal carotid artery
  • Cardio-embolic nature of ischemic stroke (a.o. atrial fibrilation, valvular prothesis, endocarditis, recent myocardialinfarction)
  • Restenosis after carotid endarterectomy
  • Acute myocardial infarction
  • Radiotherapy-induced carotid stenosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No intervention
Diagnostic test: Carotid ultrasound
  • Ultra-COMPASS measurements (longitudinal + cross-sectional) Shear wave elastography: plaque stiffness Strain elastrogaphy: plaque deformation B-mode visualization: geometry
  • Intima-media thickness
  • Pulse wave velocity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alterations in plaque composition
Time Frame: 6 and 12 weeks
Change in plaque composition (= change in plaque stiffness) measured with Ultra-COMPASS measurements (i.e. shear wave and strain elastography and plaque geometry) in patients with and without a change in lipid-lowering medication regimen
6 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent cardiovascular events
Time Frame: up to 12 weeks after brain infarction/TIA
Determine the association between Ultra-COMPASS measurements (i.e. shear wave and strain elastography and plaque geometry) and recurrent cardiovascular events (TIA / cerebral infarction / myocardial infarction / death due to cardiovascular disease)
up to 12 weeks after brain infarction/TIA
Lipoprotein level effect
Time Frame: 6 and 12 weeks after ischemic stroke (if known).
Determine the association between Ultra-COMPASS measurements (i.e. shear wave and strain elastography and plaque geometry) and (changes in) low-density lipoprotein levels (if known).
6 and 12 weeks after ischemic stroke (if known).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

August 19, 2021

First Submitted That Met QC Criteria

August 25, 2021

First Posted (Actual)

August 31, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 12, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL77726.091.21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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