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Stroke incidence and cognitive outcomes of intracranial atherosclerotic stenosis: study protocol for a multicenter,
Qianqian Si1, Yuming Teng1, Caiyan Liu1
1Department of Neurology, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.
Insights
Intracranial atherosclerotic stenosis (ICAS) increases stroke risk and cognitive decline. The SICO-ICAS study investigates its causes and outcomes to improve diagnosis and treatment for affected patients.
Area of Science:
- Neurology
- Vascular Medicine
- Cognitive Science
Background:
- Intracranial atherosclerotic stenosis (ICAS) is a major cause of stroke, yet current diagnostics and treatments are insufficient for plaque vulnerability and stroke recurrence.
- Asymptomatic ICAS poses a significant risk for cognitive impairment, with its underlying pathogenesis remaining largely unknown.
- Understanding the complex interplay of factors contributing to stroke and cognitive decline in ICAS is crucial for effective management.
Purpose of the Study:
- To elucidate the pathophysiology of stroke and cognitive impairment in patients with ICAS.
- To comprehensively evaluate interactions between life-course exposures, genetic variations, vascular risk factors, cerebrovascular burden, and neurodegeneration in the ICAS population.
- To establish a large prospective cohort for advancing ICAS research.
Main Methods:
- A multicenter, prospective, observational cohort study involving 3,000 patients with symptomatic or asymptomatic ICAS (>50% stenosis or occlusion).
- Participants will undergo detailed assessments including magnetic resonance imaging, blood biomarkers, and cognitive function tests.
- Follow-up includes 6-month clinical visits and 3-month telephone interviews for at least 12 months.
Main Results:
- The study aims to identify novel biomarkers for vulnerable intracranial plaques.
- It seeks to identify individuals at high risk for incident ischemic stroke or cognitive impairment.
- Primary outcome is the incidence of ischemic stroke or cognitive impairment within 12 months.
Conclusions:
- The SICO-ICAS study will establish a valuable prospective cohort for ICAS research.
- Findings are expected to lead to the discovery of new biomarkers and risk stratification tools.
- The ultimate goal is to inform precise diagnostic and treatment strategies for the ICAS population.
Background:
Intracranial atherosclerotic stenosis (ICAS) is one of the leading causes of stroke worldwide. Current diagnostic evaluations and treatments remain insufficient to assess the vulnerability of intracranial plaques and reduce the recurrence of stroke in symptomatic ICAS. On the other hand, asymptomatic ICAS is associated with an increased risk of cognitive impairment. The pathogenesis of ICAS related cognitive decline is largely unknown. The aim of SICO-ICAS study (stroke incidence and cognitive outcomes of ICAS) is to elucidate the pathophysiology of stroke and cognitive impairment in ICAS population, comprehensively evaluating the complex interactions among life-course exposure, genomic variation, vascular risk factors, cerebrovascular burden and coexisting neurodegeneration.
Methods:
SICO-ICAS is a multicenter, prospective, observational cohort study. We aim to recruit 3,000 patients with symptomatic or asymptomatic ICAS (>50% or occlusion) who will be followed up for ≥12 months. All participants will undergo pre-designed magnetic resonance imaging packages, blood biomarkers testing, as well as detailed cognitive domains assessment. All participants will undergo clinical visits every 6 months and telephone interviews every 3 months. The primary outcome measurement is ischemic stroke or cognitive impairment within 12 months after enrollment.
Discussion:
This study will establish a large prospective ICAS cohort, hopefully discover new biomarkers associated with vulnerable intracranial plaques, identify subjects at high risk for incident ischemic stroke or cognitive impairment, and eventually propose a precise diagnostic and treatment strategy for ICAS population.
Trial Registration:
Chinese Clinical Trials Register ChiCTR2200061938.
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