Norwegian Carotid Plaque Study

NCT02759653 | Completed

• 1 other identifier: 2015/1217
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Carotid Artery Disease; Embolic Stroke

Outcome Measures

Primary Outcomes (1)

• Ischemic stroke or TIA documented by Medical record

  3 months

Secondary Outcomes (1)

• Any arterial event documented by Medical record (composite)

  3 months

Study Arms (2)

Symptomatic

Symptomatic carotid artery disease

Asymptomatic

Asymptomatic carotid artery disease

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Symptomatic carotid artery disease
• Asymptomatic carotid artery disease

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (1)

• 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.

  PMID: 34489850 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Carotid Artery Diseases; Embolic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: May 3, 2016
• Study Start: May 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 15, 2021

Record last verified: 2016-08

Locations

NO (1)