Evaluation of the Effectiveness of Surgical and Diagnostic Techniques in Patients With Steno-occlusive Diseases of the Cerebral Vessels
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- STA-MCA bypass patency
研究概览
简要总结
This study attempts to improve surgical treatment outcomes among people with chronic carotid artery occlusive disease by conducting a comprehensive review of neuroradiological, clinical, and cognitive data. The evaluation involves an extensive angiographic analysis, including pre- and postoperative measurements of superficial temporal artery branch diameters, assessment of the Circle of Willis and collateral pathways, alongside cerebral perfusion metrics, cognitive status, and clinical outcomes. Major focus is directed towards evaluating the degree of intracranial revascularization following to extracranial-intracranial bypass by postoperative angiographic evaluations. This integrative strategy aims to refine surgical reasons, better predictions of functional and cognitive outcomes, minimize postoperative risks, and eventually improve the overall efficacy of treatment in this patient population.
详细描述
Patient selection. Patients with asymptomatic or symptomatic ICA occlusion undergoing STA-MCA bypass at the neurosurgical center will be prospectively enrolled between August 2025 and December 2027. Prior to registration, all participants will provide written informed permission in compliance of the Declaration of Helsinki's ethical guidelines.
Preoperative evaluation will include computed tomography angiography (CTA), magnetic resonance imaging (MRI), digital subtraction angiography (DSA), and comprehensive neurological and neuropsychological assessments. Magnetic Resonance Imaging also will be employed to exclude patients with extensive territorial infarctions. Only patients with radiologically confirmed ICA occlusion and arterial spin labeling (ASL) MRI-documented cerebral hypoperfusion in the affected vascular territory who undergo STA-MCA bypass will be included.
The study cohort will be recruited at the National Center for Neurosurgery in Astana through a multidisciplinary collaboration involving neurosurgeons, radiologists, neurologists, and neuropsychologists. All data will be collected using standardized case report forms and subsequently entered into a unified, secure database. Patient confidentiality will be ensured through strict coding and anonymization of personal identifiers and medical record identification numbers (MRINs).
Study variables. Data collection will include the following variables:
Demographic characteristics: Age, gender, birthplace, nationality, employment status, profession, and education level. Medical history: Past medical and surgical history, onset of TIA or stroke, vascular risk factors (hypertension, diabetes mellitus, dyslipidemia, atrial fibrillation), comorbidities (including genetic disorders), previous surgeries, ongoing follow-up care, current medications, and BMI. Clinical, neurological, and cognitive status: Baseline neurological examination findings, Modified Rankin Scale (mRS) and National Institutes of Health Stroke Scale (NIHSS) scores, history of seizures, quality-of-life measures, cognitive reserve indicators (educational attainment and occupational complexity), and engagement in cognitively stimulating activities will be assessed. Lifestyle factors: Smoking status, dietary habits, physical activity, alcohol consumption, sleep quality, vacation frequency, tobacco use, and other lifestyle factors. Radiological and hemodynamic parameters: Location and length of the internal carotid artery occlusion; collateral circulation patterns; Circle of Willis configuration; ASL perfusion metrics; cerebral blood flow (CBF) asymmetry indices; infarct burden; white matter hyperintensities; and postoperative bypass patency and the diameter of STA pre and postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ICA occlusion confirmed by CTA, MRA, and cerebral DSA.
- •MRI ASL-confirmed hypoperfusion in the territory of the occluded ICA (decrease of ≥30% compared with the contralateral side)
- •Language comprehension is preserved, with mild or no motor aphasia and no significant cognitive impairment.
- •Patients aged from 18 to 80 years.
- •Modified Rankin Scale (mRS) score 0-
- •Informed consent is available from the patient or legal guardian.
- •Accessible and reliable patients for follow-up
排除标准
- •Patients with large territorial infarction or marked cerebral atrophy on MRI.
- •No evidence of regional hypoperfusion on ASL MRI relative to the contralateral hemisphere.
- •Patients with a non-functioning STA-MCA bypass
- •Patients aged under 18
- •Patients with severe somatic conditions or mRS score > 3
- •Patients with bilateral ICA occlusion, neurovascular disease (cerebral aneurysm or arteriovenous malformation)
- •Patients with Contraindications to MRI, CTA, or DSA
- •Cardiac conditions associated with a high risk of cerebral embolism, including prosthetic heart valves, infective endocarditis, intracardiac thrombus, sick sinus syndrome, cardiac myxoma, or cardiomyopathy with left ventricular ejection fraction <25% (atrial fibrillation, patent foramen ovale, and atrial septal aneurysm are not exclusion criteria).
- •Severe systemic comorbidities, life expectancy <2 years, or a modified Rankin Scale (mRS) score >
- •Contraindications to MRI, CTA, DSA, iodinated contrast agents, or antiplatelet therapy required in the perioperative period.
- •Participation in another interventional or experimental trial within the previous 12 months, including studies involving ionizing radiation
研究组 & 干预措施
patients with chronic occlusive internal carotid artery cerebrovascular disease
干预措施: Revascularization/Conservative management (Procedure)
结局指标
主要结局
STA-MCA bypass patency
时间窗: From enrollment to the further follow-up of 6, 12, and 24 months.
Patency of the extracranial-intracranial bypass will be assessed using CTA of the head and neck and classified as patent or occluded.
Donor superficial temporal artery caliber
时间窗: 6, 12, and 24 months after surgery
Diameter of the donor superficial temporal artery branch at the anastomosis site measured using CTA imaging.
Cerebral perfusion changes
时间窗: 6, 12, and 24 months after surgery
Quantitative cerebral perfusion parameters assessed using MR perfusion imaging with 3D segmentation and compared with preoperative baseline values.
次要结局
- Global cognitive function(Preoperatively; at discharge; 6, 12, and 24 months after surgery)
