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| Name | Class |
|---|---|
| National Research, Development and Innovation Office | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carotid endarterectomy | Other | All patients in this study will undergo carotid endarterectomy procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zsuzsanna Mihály, MD | Contact | +36-20-666-3673 | zsuzsannamihaly@gmail.com | |
| Claudia Halász | Contact | +36-20-666-3227 | halasz.claudia@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Péter Sótonyi, MD PhD | Semmelweis University Heart and Vascular Centre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University Heart and Vascular Centre | Recruiting | Budapest | Budapest XII | 1122 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39460849 | Derived | 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. |
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| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| D002542 | Intracranial Embolism and Thrombosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D016894 | Endarterectomy, Carotid |
| D017585 | Ultrasonography, Doppler, Transcranial |
| ID | Term |
|---|---|
| D004691 | Endarterectomy |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
|
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D004453 | Echoencephalography |
| D009485 | Neuroradiography |
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011859 | Radiography |
| D014463 | Ultrasonography |
| D018608 | Ultrasonography, Doppler |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |