Neurological Complication of Infective Endocarditis: A Prospective Multi-site Cohort Study With Systematic MRI and Digital Subtraction Angiography
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- The assess the occurrence of infectious intracranial aneurysms in proven infective endocarditis
研究概览
简要总结
The main objective of this study is to better estimate the rate of infectious intracranial aneurysms (IIA) in proved infective endocarditis (IE). It also aims to identify MRI markers capable of accurately predicting (or excluding) IIA; to assess the impact of the different MRI abnormalities on the outcome; to capture the real-world management of EI with neurological complications in comprehensive IE centers in France
详细描述
Rationale:
The incidence of Infective endocarditis (IE) in developed countries is approximately 3-15 per 100,000 pers-years. Discharge mortality remains 15-30% and therapeutic management suffers in many ways from the paucity of randomized studies.(1) Symptomatic neurological complications, which occur in 15 to 30% of patients, are the most frequent extra-cardiac complication of IE and are deemed to worsen the outcome of EI.(2,3) Among this overall neurological complications, Infectious Intracranial Aneurysms (IIA) are a relatively rare, yet probably underestimate, vessel wall injury caused by septic emboli, with potentially intracranial bleeding for the patients.
Neuroimaging in the context of IE has gained wide acceptance and is encouraged in the current guidelines.(4,5) Nevertheless the benefit of early neuroimaging to optimize the initial therapeutic management remains debated.(6,7) While the appearance and the frequency of the various neurologic complications of EI are well known thanks to prospective cohort studies with systematic pre-therapeutic MRI(8-10), several clinically relevant questions are still unknow or approximate, including: 1/ What is the rate of IIA in proved EI. The current gold standard for the detection of these small and distally located aneurysms remains Digital Subtraction Angiography (DSA) and to our knowledge, there is no prospective unbiased cohort of IE with systematic DSA available in the literature. 2/ Are there MRI signs correlated with the presence of IIA on DSA? Several MRI markers such as sulcal SWI lesion or cerebral microbleeds (CMBs) with contrast enhancement look promising (10), but validation in unbiased prospective studies with systematic MRI and DSA is needed. 3/ What is the impact on the outcome of the different MRI abnormalities and of unruptured and ruptured IIA? As previously mentioned, the value of both MRI and DSA remain unclear to guide the acute therapeutic management of EI. A recent French survey highlighted differences between university Hospital in France in the management of IIA. Thus, the analysis of the current management of EI with neurological complications could also help at informing the design of future randomized trials.
Questions:
- Better estimate the rate of IIA in proved EI.
- Identify MRI markers able to accurately predict (or exclude) IIA.
- What is the impact of different MRI abnormalities on the outcome?
- Capture the real-world management of EI with neurological complications in comprehensive EI centers in France
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with left-sided active infective endocarditis (IE) satisfying modified Duke Criteria,
- •patients who underwent both digital subtraction angiography (DSA) and brainMRI (as part of routine care)
- •DSA protocol with 3D rotational for both carotids and one vertebral artery
- •MRI/MRA standardized protocol including at least: Diffusion, FLAIR, 3D SWI, 3DT1SE and post gadolinium 3DT1SE and 3D TOF (large field: from the vertex to the magnum foramen).
排除标准
- •uncertain diagnosis of IE by infectious disease consultants
- •patients with chronic IE
- •MRI performed after the completion of Infectious intracranial aneurysms (IIA) treatment
- •MRI performed without contrast injection or complete protocol
- •More than 48-hours delay between performing MRI and DSA
结局指标
主要结局
The assess the occurrence of infectious intracranial aneurysms in proven infective endocarditis
时间窗: 3 months
In all included cases, infectious intracranial aneurysms will be detected using cerebral Digital Subtraction Angiography (DSA), which remains the current gold standard for the detection of these small and distally located aneurysms. DSA protocol will include 2D and 3D rotational acquisitions on both carotid arteries and one vertebral artery. The number of infective endocarditis with infectious intracranial aneurysms will be referred to the total number of endocarditis to estimate the incidence of these cerebral anomalies.
次要结局
- To assess the diagnostic performance of MRI markers to detect infectious intracranial aneurysms(3 months)
- To assess the predictive performance of imaging markers on clinical outcome(2 years)
- To assess the rate of symptomatic intracranial haemorrhage following heart surgery(6 months)
研究者
Basile Kerleroux
MD-MSc
the Jeunes en Neuroradiologie Interventionnelle (JENI) research group