Carotid Artery PlaqueUltra-COMPASSNCT05029661
Ultrasound Elastography for Individual Carotid Plaque Stratification
An observational study of Carotid Artery Plaque, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Plaque
- What is being tested?
- Carotid ultrasound
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Nov 2021to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud university medical center
Nijmegen, Gelderland, 6525 GA
Judith Pruijssen, +31243614730, judith.pruijssen@radboudumc.nl
About this study
Official title: 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:
Read more
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.
- Conditions
- Carotid Artery Plaque
- Being tested
- Carotid ultrasound
- Keywords
- Ultrasound, Shear wave elastrography, Lipid-lowering medication, Atherosclerotic plaques
- Medical subject headings
- Carotid Stenosis, Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid ultrasoundDiagnostic test
- 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
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention Receives: Diagnostic Test: Carotid ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alterations in plaque composition
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
Measured: 6 and 12 weeks
Secondary outcomes (2)
Recurrent cardiovascular events
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)
Measured: up to 12 weeks after brain infarction/TIA
Lipoprotein level effect
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).
Measured: 6 and 12 weeks after ischemic stroke (if known).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start10 Nov 2021
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery PlaqueStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029661
- Sponsor's protocol ID
- NL77726.091.21
- Acronym
- Ultra-COMPASS
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2021
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrafast Ultrasonic COMpound Push Wave imAging and Strain eStimation (Ultra-COMPASS) for Individual Plaque Stratification in the Carotid Arteries
- ClinicalTrials.gov ID
- NCT05029661
- Acronym / sponsor ID
- Ultra-COMPASS / NL77726.091.21
- Conditions
- Carotid Artery Plaque
- Keywords
- Ultrasound, Shear wave elastrography, Lipid-lowering medication, Atherosclerotic plaques
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No intervention | – | Diagnostic Test: Carotid ultrasoundNo intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | No intervention |
Primary outcome
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
2 secondary outcomes
Recurrent cardiovascular events
Time frame: up to 12 weeks after brain infarction/TIA
Lipoprotein level effect
Time frame: 6 and 12 weeks after ischemic stroke (if known).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Plaque, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alterations in plaque composition (time frame: 6 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.