An observational study in Carotid Artery Diseases, Carotid Atherosclerosis and Carotid Artery Stenosis, sponsored by State Institution "Republican Scientific and Practical Center" Cardiology, Belarus. Recruiting at 1 site in Belarus. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by State Institution "Republican Scientific and Practical Center" Cardiology, Belarus · Observational
Cerebral hyperperfusion syndrome (CHS) was initially described as a clinical complication following carotid endarterectomy (CEA), but it may occur after both CEA and carotid artery stenting. It is characterised by throbbing ipsilateral frontotemporal or periorbital headache, and sometimes diffuse headache, eye and facial pain, vomiting, confusion, macular oedema, visual disturbances, focal motor seizures with frequent secondary generalisation, focal neurological deficits, and intracerebral or subarachnoid haemorrhage.
Knowledge of CHS among physicians remains limited. Most studies report an incidence of 1-3% after carotid endarterectomy. CHS is most common in patients with increases of more than 100% in cerebral perfusion compared with baseline after carotid revascularization, and is rare in patients with perfusion increases of less than 100% compared with baseline.
The pathophysiological mechanism of CHS is only partially understood. The chronic low-flow state induced by severe carotid disease results in compensatory dilation of cerebral vessels distal to the stenosis, as part of the normal autoregulatory response to maintain adequate cerebral blood flow (CBF). In this chronically dilated state, the vessels lose their ability to autoregulate vascular resistance in response to changes in blood pressure. Dysautoregulation has been shown to be proportional to the duration and severity of chronic hypoperfusion. After revascularization and reperfusion, impaired cerebral autoregulation may contribute to a cascade of intracranial microcirculatory changes, with an inability to respond adequately to the augmentation of CBF following carotid recanalization.
Although most patients present with mild symptoms and signs, progression to severe and life-threatening complications can occur if CHS is not recognised and treated promptly. Because CHS is diagnosed on the basis of several non-specific signs and symptoms, patients may be misdiagnosed as having one of the better-known causes of perioperative complications, such as thromboembolism.
364 studies on the registry are indexed under Carotid Stenosis; 85 are open to participants now.
This study's planned enrollment of 500 is above the median of 176 across 159 observational studies indexed under Carotid Stenosis.
Browse Carotid Stenosis studies →State Institution "Republican Scientific and Practical Center" Cardiology, Belarus is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Compared within Carotid Stenosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Carotid Artery Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients who will undergo carotid revascularization procedures
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Carotid revascularization
Procedure: Carotid revascularization
Carotid revascularization
Number of Participants with Cerebral Hyperperfusion Syndrome
The diagnosis of cerebral hyperperfusion syndrome will be based on the following criteria: 1. Appearance of symptoms within 1 month after surgery. 2. First-time unilateral headache, convulsions, hemiparesis/hemiplegia, visual disturbances, ataxia, Glasgow Coma Scale score \< 15 points, aphasia, or signs of cerebral edema or intracerebral hemorrhage. 3. Symptoms of "luxury perfusion syndrome" occurring within the first 24-48 hours after restoration of blood flow through the internal carotid artery. 4. Increase in cerebral blood flow in the middle cerebral artery \> 100% compared with the preoperative value, measured by transcranial Doppler ultrasonography. 5. Exclusion of differential diagnoses, including hypertensive encephalopathy, reversible posterior leukoencephalopathy syndrome, and reversible cerebral vasoconstriction syndrome. 6. Neurological symptoms occurring in the context of high blood pressure.
Time frame: Occurrence of symptoms within 30 postoperative days
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for May 2028, 60 months after the start.
Of 79 non-industry observational studies under Carotid Stenosis, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 104. This study's planned 60 months is above that.
Counting every sponsor, half of 87 studies reached it within 50 months; a quarter within 30 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
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State Institution "Republican Scientific and Practical Center" Cardiology, Belarus