Evaluation of Cerebrovascular Events in Patients With Occlusive Carotid Artery Disorders
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|ClinicalTrials.gov Identifier: NCT03840265|
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 19, 2019
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, 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.
|Condition or disease||Intervention/treatment||Phase|
|Carotid Stenosis Carotid Artery Plaque Cerebrovascular Embolism and Thrombosis||Procedure: carotid endarterectomy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Cerebrovascular Events in Patients With Occlusive Carotid Artery Disorders Based on Morphological and Hemodynamical Features|
|Actual Study Start Date :||February 6, 2019|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||November 30, 2022|
All patients in this study will undergo carotid endarterectomy procedure
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
- Neurological event [ Time Frame: Periprocedural (0-78h after the carotid endarterectomy) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03840265
|Contact: Zsuzsanna Mihály, MDemail@example.com|
|Contact: Andrea Mészárosfirstname.lastname@example.org|
|Semmelweis University Heart and Vascular Centre||Recruiting|
|Budapest, Budapest XII, Hungary, 1122|
|Contact: Zsuzsanna Mihály +36-20-666-3673 email@example.com|
|Study Director:||Péter Sótonyi, MD PhD||Semmelweis University Heart and Vascular Centre|