Evaluation of Cerebrovascular Events in Patients With Occlusive Carotid Artery Disorders

NCT03840265 | Unknown

• 1 other identifier: SemmelweisUHVC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Neurological event

  Neurological event can be definitive stroke or transient ischemic attack (TIA). Any neurological events, which can occur in the postoperative 0-78 hours is defined as neurological event. The patients with neurological event will be scored in Rankin scale and will undergo cranial CT and CTA to verify the acute brain ischemia. Patients without any neurological event, who has silent new DWI lesions in postoperative cranial MR, count to be asymptomatic and do not fulfill the positive outcome criteria. Patients with peripheral nerve damage (common complication of cervical operations) count to be asymptomatic and do not fulfill the positive outcome criteria.

  Periprocedural (0-78h after the carotid endarterectomy)

Study Arms (1)

Carotid endarterectomy

OTHER

All patients in this study will undergo carotid endarterectomy procedure

Procedure: carotid endarterectomy

Interventions

carotid endarterectomy PROCEDURE

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

Also known as: Cranial MR, Transcranial Doppler Ultrasound, Optical coherence tomography angiography, Carotid CT angiography

Carotid endarterectomy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signed informed consent,
• significant carotid artery stenosis

You may not qualify if:

• Age under 50 years
• Neurological event 15 days before operation
• Chronic kidney disease
• Pacemaker or ICD implantation
• Atrial fibrillation

Sponsors & Collaborators

• Semmelweis University Heart and Vascular Center: lead
• National Research, Development and Innovation Office: collaborator

Study Sites (1)

Semmelweis University Heart and Vascular Centre

Budapest, Budapest XII, 1122, Hungary

RECRUITING

MeSH Terms

Conditions

Carotid Stenosis; Intracranial Embolism and Thrombosis

Interventions

Endarterectomy, Carotid; Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Endarterectomy; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Péter Sótonyi, MD PhD

  Semmelweis University Heart and Vascular Centre

  STUDY DIRECTOR

Central Study Contacts

Zsuzsanna Mihály, MD

CONTACT

+36-20-666-3673; zsuzsannamihaly@gmail.com

Claudia Halász

CONTACT

+36-20-666-3227; halasz.claudia@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Head of Vascular Surgery Department of Semmelweis University

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 15, 2019
• Study Start: February 6, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2022
• Last Updated: March 20, 2020

Record last verified: 2020-03

Locations

HU (1)