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Carotid StenosisNCT03840265

Evaluation of Cerebrovascular Events in Patients With Occlusive Carotid Artery Disorders

A study testing carotid endarterectomy in people with Carotid Stenosis and Carotid Artery Plaque, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
carotid endarterectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteHungary
Study dates
6 Feb 2019to 30 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • signed informed consent,
  • significant carotid artery stenosis

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Hungary1 site, 1 recruiting
  • Semmelweis University Heart and Vascular Centre

    Budapest, Budapest XII, 1122

    Zsuzsanna Mihály, +36-20-666-3673, zsuzsannamihaly@gmail.com

    Recruiting

Other trials in Hungary

About this study

Official title: Evaluation of Cerebrovascular Events in Patients With Occlusive Carotid Artery Disorders Based on Morphological and Hemodynamical Features

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.

Read the detailed description

Stroke is one of the leading causes of mortality in Hungary. While stroke mortality is 8-10/100.000 in the population under 50 years of age in Western European countries, the mortality is 40/100.000 in women and 60/100.000 in men in Hungary. In the investigators' country the stroke patients are 5-10 years younger as compared to other developed countries. The total stroke mortality in the first 24 months in Hungary is approximately 30%, furthermore 32-42% of the survivors need permanent help in completing their daily routine tasks. Carotid artery disease of atherosclerotic origin is common in the elderly population. The cause of cerebral ischemia in approximately half of the patients is due to the rupture of atherosclerotic plaque with subsequent embolization of thrombus and/or plaque material in the cerebral circulation. Prevention of cerebral ischemia is the goal of pharmacological or surgical treatment. The decision for surgical treatment such as carotid endarterectomy (CEA) or carotid artery stenting (CAS) is based on the degree of stenosis, but incorporating non-invasive measures of plaque composition is expected to improve the selection of patients that will benefit from surgical intervention. The number of asymptomatic patients with carotid stenosis needed to treat to prevent one stroke with endarterectomy is 20, which is quite high compared to 8 in the symptomatic patient group. There is a clear need to identify asymptomatic individuals at high risk of developing future ischemic events to avoid unnecessary surgery. It has been remarked, that the recent AHA (American Heart Association) guideline on the management of significant asymptomatic carotid stenosis recommends that surgery may be considered in highly selected patients. However, no guidance was provided as to which patient is the "highly selected" one.

As of today, no suitable 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 for low risk patients. Unfortunately there is no proven and widely accepted system to distinguish these two categories of patients with carotid artery stenosis.

Aims:

The investigators' aim is to establish a stroke risk prediction score system -based on CTA and US plaque morphology and blood sample biomarkers- for asymptomatic carotid artery stenosis patients. A more specific and more accurate system -than the currently applied stroke risk score systems- would allow for the selection of the potentially high risk plaques in asymptomatic patients with borderline grade stenosis.These patients would benefit more from surgical treatment while asymptomatic patients with low risk plaques could avoid the risk of an invasive treatment.

  1. Morphological features related to surgical related cerebrovascular events: The investigators plan to overview the clinical records retrospectively to find morphological, hemodynamical and clinical predictors of intra- and early postoperative cause of the cerebrovascular events. An isolated middle cerebral artery carries higher risk of immediate neurological event after carotid endarterectomy with cross-clamping without shunt protection. This project's secondary aims are the following: to compare the accuracy of the CTA and MR imaging in the assessment of the Circle of Willis (CoW) morphology in all patients before CEA and to evaluate changes in CoW morphology before and after CEA, to compare ischemic changes before and after CEA regarding CoW morphology, shunt usage and to evaluate the impact of contralateral carotid occlusion on immediate neurological event (INE) regarding CoW and other supra-aortic morphology. Retrospective assessment of the correlation between intracranial vascular morphology with CTA and intraoperative stroke risk would provide help in perioperative stroke risk prediction and planning of optimal surgical technique.
  2. Micro-embolization and carotid plaque analysis: The investigators aim is to define a group of patients in the study cohort, who are clinically asymptomatic, but suffered silent brain ischemia (SBI) before surgery, and to analyze their plaque using a dedicated software for plaque assessment (Medis QAngioCT) and compare to asymptomatic without SBI and symptomatic patients plaques. In Hungary the gold standard of the preoperative imaging of carotid artery stenosis in asymptomatic and symptomatic patients is CTA. These images can be used for plaque analysis that is to identify vulnerable plaque morphology in coronary arteries. The identification of preoperative plaque vulnerability based on the comparison of the ultrasound plaque elastography and contrast enhanced plaque analysis, the transcranial Doppler ultrasound (which can detect microembolisation), cranial DWI-MR for verification of silent recent ischaemic lesions and the histopathology of surgically removed plaques with CTA and US based plaque morphology can define vulnerable plaques related to adverse events.
  3. Evaluation of retinal perfusion changes following carotid interventions using OCT angiography in patients with carotid stenosis to assess the influence of carotid stenting and carotid endarterectomy on retinal perfusion using OCTA in patients with significant carotid artery stenosis. Furthermore, this study evaluates the predictive accuracy of retinal microvasculature alterations on the development of postoperative stroke. Carotid artery occlusive disease may result in different vision threatening ocular manifestations, for instance, retinal vascular occlusions and ocular ischemic syndrome (OIS). The diagnosis of carotid stenosis is critical as it is an important risk factor of serious cerebrovascular disease. OCT angiography could be a useful non-invasive method for early diagnosis of patients with carotid stenosis and to evaluate the outcome of carotid interventions. Better identification of patients with carotid stenosis is crucial for the prevention of vision loss and stroke.
Being tested
carotid endarterectomy
Medical subject headings
Carotid Stenosis, Intracranial Embolism and Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • carotid endarterectomyProcedure or surgery

    Also called Cranial MR, Transcranial Doppler Ultrasound, Optical coherence tomography angiography, Carotid CT angiography

    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

Study groups in NCT03840265
Study groupRoleWhat they receive
Carotid endarterectomyOtherAll patients in this study will undergo carotid endarterectomy procedure
Receives: Procedure: carotid endarterectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Periprocedural (0-78h after the carotid endarterectomy)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2019
  2. Study start6 Feb 2019
  3. Primary completion30 Nov 2020 (estimated)
  4. Study completion30 Nov 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03840265
Sponsor's protocol ID
SemmelweisUHVC
Status last verified
Mar 2020
First submitted
12 Feb 2019
Last updated
20 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Czinege Z, Sandor AD, Gyurki D, Varga A, Csipo T, Szekely A, Ungvari Z, Banga P, Sotonyi P, Horvath T. Understanding perioperative risk determinants in carotid endarterectomy: the impact of compromised circle of Willis morphology on inter-hemispheric blood flow indices based on intraoperative internal carotid artery stump pulse pressure and backflow patterns. Geroscience. 2025 Apr;47(2):2159-2177. doi: 10.1007/s11357-024-01390-y. Epub 2024 Oct 26.

    PubMed 39460849

Questions about this trial

What is this clinical trial studying?

A study testing carotid endarterectomy in people with Carotid Stenosis and Carotid Artery Plaque, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zsuzsanna Mihály, MD (+36-20-666-3673, zsuzsannamihaly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurological event (time frame: Periprocedural (0-78h after the carotid endarterectomy)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03840265, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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