About 20% of stroke causes are atherosclerotic strokes caused by carotid artery stenosis.
In 2005, 92% of carotid artery interventions in the USA were performed in asymptomatic patients. It should be noted that screening in the general population for carotid artery disease is unwarranted, due to uncertain eligibility criteria for interventional treatment of asymptomatic patients. On the other hand, 10-15% of all patients with a first-ever stroke will experience an ischemic stroke as a result of previously untreated, asymptomatic, significant carotid artery stenosis.
Carotid artery angioplasty with stent placement (CAS) has become the second method of revascularization. ed, however, there is a great deal of ambiguity in the application of these criteria, which stems from the ratio of the risk to the possible benefit to the patient of performing the procedure, as well as the cost-effectiveness for health care systems.
OBJECTIVES The overall goal is (following the model of measuring fractional flow reserve - FFR) to try to establish a new parameter that could prove helpful in qualifying patients for percutaneous internal carotid artery angioplasty with stent implantation (CAS). Determining whether measuring the pressure gradient across the stenosis will determine which patients will benefit from the CAS procedure. In the absence of convincing evidence on the effects of CAS, especially for so-called asymptomatic patients, it is advisable to establish a parameter that would complement the eligibility criteria that, on the one hand, could prevent strokes in the population of patients with silent internal carotid artery stenosis and, on the other hand, avoid performing the procedure in the absence of benefit.
PRIMARY ENDPOINTS:
1. Assessment of cerebral perfusion by magnetic resonanse before and after CAS 2. Assessment of cognitive symptoms using before and after CAS 3. Assessment of neurological symptoms before and after CAS 4. Assessment of otolaryngological symptoms before and after CAS
SECONDARY ENDPOINTS:
Creation of a non-invasive computed tomography protocol with pressure gradient assessment in patients with carotid artery stenosis.
A final version of the algorithm based on a new diagnostic measurement (concentration gradient) ready to be used in the diagnosis of CAS-eligible patients with an implemented function for automatic classification of measurement results that will indicate the group of patients who will benefit from the CAS procedure.
Stenosis of the internal carotid artery in symptomatic patients: > 50%, (confirmed by non-invasive imaging studies: USG, angio-CT), qualified for angioplasty with stent implantation
Stenosis of the internal carotid artery in asymptomatic patients: >60%, (confirmed by non-invasive imaging studies: USG, angio-CT), qualified for angioplasty with stent implantation
Age of patients: > 18 years of age
Provided informed consent to participate in the study.
Inability to obtain informed consent to participate in the study.
Difficult anatomy of the aortic arch and the descending cephalic arteries (increased atherosclerotic lesions, acute angle of departure of the common carotid arteries, kinking of the internal carotid arteries).
Parallel
CAS + Intravascular measuring the pressure gradient
Procedure/SurgeryMeasurements taken during the procedure during CAS * placement of a "FFR"- micro catheter on the neuroprotection wire and taking a measurement before the stenosis and in the internal carotid artery above the stenosis * reading the pressure gradient after obtaining a stable value (a minimum of 5 cardiac cycles) * the study of intravascular pressure measurements will be performed using a special micro catheter
CAS (standard)
Procedure/SurgeryAnimation of blood pressure measurements on the "FFR" console without actual measurement in carotid artery ("blinding" of the study to the patient) during CAS procedure.
Doppler ultrasonound of cephalic arteries
Diagnostic testnon-invasive assessment of carotid stenosis before surgery and assessment of results after CAS (3 and 12 months after CAS)
Angio-CT of the neck and head
RadiationNon-invasive pre-operative assessment and post-CAS result (3 months after)
Otolaryngological examination
Other interventionHearing and balance tests (before and after CAS) - prospective follow-up
Psychological examination
Other interventionpsychological examination with questionnaires (before and after CAS) - prospective follow-up
Neurological examination
Other interventionneurological examination with questionnaires (before and after CAS) - prospective follow-up
MR cerebral perfusion
Diagnostic testAssessment of the cerebral perfusion alterations using DSC (dynamic susceptibility contrast) MR perfusion, before and after CAS (after 3 months): Parametric maps of cerebral blood flow (CBF), cerebral blood volume (CBV), time to peak (TTP), and mean transit time (MTT) will be generated and used for the qualitative and quantitative analyses of the following perfusion parameters: * cerebral blood volume (CBV) value in ml/100ml; * cerebral blood flow (CBF) value in ml/100ml/min; * mean transit time (MTT) value in seconds * time to peak (TTP) value in seconds
Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on changes in cerebral perfusion after surgery
Composite endpoint including: Assessment of the predictive capabilities of the obtained pressure gradient values * on changes in cerebral perfusion after surgery (assessment of the cerebral perfusion alterations using DSC (dynamic susceptibility contrast) MR perfusion, before and after CAS
Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on neurological status
Composite endpoint including: \- changes in neurological status (assesed by the MMSE, mini-mental state examination; NIHSS, National Institutes of Health Stroke Scale),
Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on mental status
Composite endpoint including: \- changes in cognitive functions (assesed by the MOCA, Montreal Cognitive Assessment - test)
Predictive capabilities of the obtained invasive pressure gradient in carotid artery stenosis on otolaryngological status in hearing functions
Composite endpoint including: \- changes in hearing functions (assesed by the audiometry, tympanometry and ipsilateral middle ear reflex, otoemission, Skarzynski Tinnitus Scale, ABR - Auditory Brainstem Response, BERA)
Algorithm angio-CT/non invasive pressure measurement in carotid
Creation a multiple regression model based on the data from non-invasive pre-procedural measurements on the incidence of unfavourable outcome measures.
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4th Military Clinical Hospital with Polyclinic, Poland
Lead sponsor
Medical Research Agency, Poland
Collaborator
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