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Evaluation of Cerebrovascular Events in Patients With Occlusive Carotid Artery Disorders

NCT03840265 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-03-20

No results posted yet for this study

Summary

As of today, no suitable multiparametric predictive method is available to properly estimate stroke risk in patients with carotid artery stenosis. Carotid artery stenosis is one of the proven risk factors of stroke incidence, but the indication of its intervention is merely the grade of stenosis itself. The current international guidelines suggest intervention for asymptomatic patients only with potentially high risk plaques but pharmacological treatment is advised to low risk patients. Unfortunately there is no proven and widely accepted system to distinguish these two categories of patients with carotid artery stenosis.

In this project the following parameters will be assessed both in asymptomatic and symptomatic patients: 1, preoperative stroke risk prediction based on comparative analysis of CT angiography (CTA) results of plaque morphology and ultrasound (US) based plaque elastography analysis, 2) intracranial bloodflow will be measured by transcranial Doppler sonography(TCD), 3) presence recent of silent brain ischemia on diffusion weighted imaging (DWI) MR (magnetic resonance), 4) retinal perfusion measurement by optical coherence tomography angiography (OCT). The investigators aim to establish a clinically meaningful and more accurate (than stenosis grade) stroke risk prediction algorithm for asymptomatic carotid stenosis patients based on these parameters.

Conditions

  • Carotid Stenosis
  • Carotid Artery Plaque
  • Cerebrovascular Embolism and Thrombosis

Interventions

PROCEDURE

carotid endarterectomy

In this project the following parameters will be assessed both in asymptomatic and symptomatic patients underwent carotid endarterectomy: 1) hemodynamic modeling of effect of the supraaortic arteries anatomic variations and pathologies 2, preoperative stroke risk prediction based on comparative analysis of CTA results of plaque morphology and ultrasound-based plaque elastography analysis, 3) cerebral flow measurement by transcranial Doppler sonography(TCD), 4) presence recent of silent brain ischemia on DWI-MRI, 5) OCT angiography could be a useful non-invasive method for evaluation of the outcome of carotid interventions

Sponsors & Collaborators

  • National Research, Development and Innovation Office

    collaborator UNKNOWN

  • Semmelweis University Heart and Vascular Center

    lead OTHER

Principal Investigators

  • Péter Sótonyi, MD PhD · Semmelweis University Heart and Vascular Centre

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-06
Primary Completion
2020-11-30
Completion
2022-11-30

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03840265 on ClinicalTrials.gov