Clinical trial NCT02759653: Norwegian Carotid Plaque Study
Official title: Norwegian Carotid Plaque Study (NOR-PLAQ). Advanced Neurosonology in Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Carotid Artery Disease
Embolic Stroke
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2016-05-03
Enrollment: 16
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic and asymptomatic carotid artery disease admitted to the Dept. of Neurology at Haukeland University Hospital, Bergen/ Norway

Brief summary: BACKGROUND: In 30-40% the cause of ischemic stroke remains undetermined. Most likely, this category hides an additional number of strokes caused by artery-to-artery embolisms due to unidentified atherosclerotic disease, or caused by cardioembolism. Both types are associated with a high risk of recurrent ischemic events and multiple cerebral infarctions.

Large-artery atherosclerosis of the brain-supplying arteries is the assumed underlying cause in 10 to 15% of ischemic stroke, mostly deriving from the extracranial carotid artery. Carotid intima-media thickness (cIMT) measured by 2-dimensional (2D) B-mode ultrasonography and estimation of the overall atherosclerotic plaque burden aids future risk prediction. Arterial wall changes, artery caliber variations, degree of stenosis, local hemodynamic alterations and certain plaque characteristics are important for the evaluation of plaque vulnerability and vascular risk stratification. Transcranial Doppler monitoring (TCDM) is a non-invasive bedside examination eligible for detection of microemboli in the human cerebral circulation.

HYPOTHESIS: Atherosclerotic stenosis and plaque characteristics can be more accurately assessed by the combination of routine 2D ultrasound, contrast enhanced ultrasound (CEUS), and 3-dimensional (3D) ultrasound. TCDM, CEUS and 3D visualization of the carotid plaque improve the differentiation of stroke etiology and quantification of plaque vulnerability, and aid the prediction of future risk for cerebrovascular events in the individual patient.

AIMS: Assessment of prevalence and frequency of Microemboli signals (MES) in unselected patients with cerebral ischemia, the influence of antithrombotic drugs on MES, and the relationship between MES and recurrent stroke or Transient ischemic attack (TIA).

Categorization of atherosclerotic carotid artery disease by use of routine and advanced neurosonographic techniques combined with anamnestic and clinical data.

Development of a visualization solution tailored for 3D visualization of carotid arteries and semi-automatic plaque segmentation.

Detailed description: * Standardized questionnaire
* Extracranial and transcranial duplexsonography
* Extracranial contrast-enhanced ultrasound
* Extracranial 3D-ultrasound
* Transcranial Doppler monitoring
* Clinical work-up incl. radiological and cardiological procedures, scoring etc

Eligibility criteria: Inclusion Criteria:

* Symptomatic carotid artery disease
* Asymptomatic carotid artery disease

Primary outcomes:
measure: Ischemic stroke or TIA documented by Medical record
timeFrame: 3 months
Secondary outcomes:
measure: Any arterial event documented by Medical record (composite)
timeFrame: 3 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
References:
citation: Aarli SJ, Thomassen L, Waje-Andreassen U, Logallo N, Kvistad CE, Naess H, Fromm A. The Course of Carotid Plaque Vulnerability Assessed by Advanced Neurosonology. Front Neurol. 2021 Aug 20;12:702657. doi: 10.3389/fneur.2021.702657. eCollection 2021.