- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05029661
Ultrasound Elastography for Individual Carotid Plaque Stratification (Ultra-COMPASS)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Gelderland
-
Nijmegen, Gelderland, Netherlands, 6525 GA
- Recruiting
- Radboud University Medical Center
-
Contact:
- Judith Pruijssen
- Phone Number: +31243614730
- Email: judith.pruijssen@radboudumc.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
No intervention
|
|
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL77726.091.21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Carotid Artery Plaque
-
University Hospital OstravaCharles University, Czech Republic; University Hospital Olomouc; University of... and other collaboratorsActive, not recruiting
-
Cambridge University Hospitals NHS Foundation TrustNot yet recruitingCarotid Artery Plaque | Carotid Atherosclerosis | TIAUnited Kingdom
-
Marc van SambeekEindhoven University of TechnologyUnknown
-
Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, FranceRecruitingCarotid Artery Plaque | Carotid Stenosis | Carotid Artery Diseases | Carotid Atherosclerosis | Atheroma; Carotid ArteryFrance
-
Canadian Medical and Surgical Knowledge Translation...AmgenRecruitingCarotid Artery Stenosis | Asymptomatic Carotid Artery StenosisCanada
-
Xuanwu Hospital, BeijingRecruitingCarotid Artery Plaque | Carotid Artery Stenting | Carotid EndarterectomyChina
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)RecruitingCarotid Artery Plaque | Carotid Stenosis | Plaque, AtheroscleroticUnited States
-
Second Affiliated Hospital, School of Medicine,...RecruitingCarotid Artery Plaque | Plaque, Atherosclerotic | Immune Checkpoint Inhibitors | Programmed Cell Death Protein 1 Inhibitor | Intimal Medial Thickness of Internal Carotid ArteryChina
-
Arizona Heart InstituteVolcano CorporationCompletedCarotid Artery DiseaseUnited States
-
Heinrich-Heine University, DuesseldorfRecruitingCarotid Artery Plaque | Carotid Artery Diseases | Carotid Artery Stenosis Asymptomatic | Carotid Artery StenosisGermany
Clinical Trials on Carotid ultrasound
-
Rush University Medical CenterIcahn School of Medicine at Mount SinaiWithdrawnMyocardial Infarction | Myocardial Ischemia | Heart Diseases | Coronary Artery Disease | Stroke | Cerebrovascular Disorders | Coronary Disease | Arteriosclerosis | Arterial Occlusive Diseases | Cardiovascular Disease | Atherosclerosis | Peripheral Vascular Disease | Cerebral Infarction | Coronary Arteriosclerosis | Cerebrovascular... and other conditions
-
First Hospital of China Medical UniversityRecruitingCarotid Artery DiseasesChina
-
University of Wisconsin, MadisonCompletedStroke | AtherosclerosisUnited States
-
M.D. Anderson Cancer CenterTerminated
-
NYU Langone HealthCompletedCoronary Artery Disease | Heart Failure | Cardiomyopathy
-
Shengjing HospitalSuperSonic ImagineActive, not recruitingCarotid Artery Diseases | Healthy VolunteersChina
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingCarotid StenosisSwitzerland
-
St. Boniface HospitalWithdrawn