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OpenTrials
Completed

NCT Number: NCT02759653

Norwegian Carotid Plaque Study

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.

Completed

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital

Bergen, 5021, Norway

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Symptomatic carotid artery disease
  • Asymptomatic carotid artery disease

Treatment and study plan

Primary outcomes

  1. Ischemic stroke or TIA documented by Medical record

    Time frame: 3 months

Secondary outcomes

  1. Any arterial event documented by Medical record (composite)

    Time frame: 3 months

    Ischemic stroke, TIA, Coronary artery disease, Myocardial infarction, Peripheral arterial disease

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • University of Bergen

Registry information

Official study title

Norwegian Carotid Plaque Study (NOR-PLAQ). Advanced Neurosonology in Acute Ischemic Stroke

Acronym: NOR-PLAQ

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 3, 2016
Registry last updated
Feb 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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