Norwegian Carotid Plaque Study

Completed

• Conditions: Embolic Stroke; Ischemic Stroke; Carotid Artery Disease

• Registration Number: NCT02759653
• Lead Sponsor: Haukeland University Hospital

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

Study Timeline

• Study First Submitted: 2016-04-26
• Study Start: 2016-05
• Study First Submitted QC: 2016-05-02
• Study First Posted: 2016-05-03
• Status Verified: 2016-08
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Last Update Submitted: 2021-02-12
• Last Update Posted: 2021-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Symptomatic carotid artery disease
• Asymptomatic carotid artery disease

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ischemic stroke or TIA documented by Medical record	3 months

Secondary Outcome Measures

Name	Time	Method
Any arterial event documented by Medical record (composite)	3 months	Ischemic stroke, TIA, Coronary artery disease, Myocardial infarction, Peripheral arterial disease

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway