Analyse du Risque de Rupture Des AnévrysMes Intracrâniens au Travers Des Déterminants Sociaux de Santé
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 1,800
- 试验地点
- 2
- 主要终点
- Study the interaction between social determinants of health (SDH) and individual factors associated with intracranial aneurysm (IA) rupture using data available in the Nantes University Hospital Data Warehouse (EDS)
研究概览
简要总结
Intracranial aneurysms (IA) are arterial malformations affecting about 3% of the overall population. Rupture is the most severe complication, as it is associated with nearly 30% of death or severe disability. The available scores to assess rupture risk are mainly based on usual modifiable and non-modifiable risk factors from the literature, but they appear insufficient to predict rupture. Emerging factors, such as sleep apnea syndrome and the use of certain medications, seem to influence the risk of rupture. The study of social determinants of health (SDOH) is highly relevant, given numerous reports showing the impact of SDOH, in addition to vascular risk factors, on vascular diseases like ischemic stroke or myocardial infarction.
It is therefore reasonable to study the interaction between rupture risk factors and SDOH on the rupture risk of IA. Several initiatives have been undertaken to assess rupture risk, but few have included SDH. Limitations were often raised, especially regarding data accessibility. However, it is now possible, thanks to artificial intelligence (AI) algorithms, particularly natural language processing (NLP), to reuse large-scale health data to address longstanding issues, such as those posed by SDH.
The use of health data warehouses (HDWs) offers an opportunity to collect and analyze accurate, real-world data, particularly through AI and NLP to extract information from medical reports. However, various challenges limit the use of NLP models, notably the dominance of models trained on English medical texts and privacy-related legislative restrictions. Therefore, alongside leveraging these models for clinical research, it is essential to continue efforts to develop transparent French-language models that comply with legislation.
Thus, the ARAMISS project proposes to study the interaction between SDH and known risk factors for IA rupture by comparing control populations and rupture cases. This study will be based on a certified health data warehouse (HDW) and an NLP algorithm previously developed by the team.
In parallel, the project plans two FAIR-compliant knowledge-sharing approaches to disseminate the algorithm and training corpus to the broader community.
详细描述
Intracranial aneurysms (IA), the most common intracranial arterial malformation, affect approximately 3% of the global population. They are characterized by a dilation of the vascular wall within the intracranial region, typically at a bifurcation. The most feared complication of IA is rupture, which is associated with high morbidity and mortality. About 30% of patients face death or severe disability, and even among those with no visible sequelae, up to 50% suffer from invisible disabilities such as cognitive problems. This explains the significant economic burden of ruptured IAs, estimated at approximately £168 million annually in the UK.
One way to reduce this morbidity and societal burden is to identify patients at high risk of rupture to determine those most likely to experience disease progression. Various initiatives, such as the ELAPSS, PHASES, and UCAS scores, have been developed to assess rupture risk in routine clinical practice. However, these scores largely rely on well-known modifiable and non-modifiable risk factors, such as ethnicity, hypertension, sex, age, smoking, and history of subarachnoid hemorrhage. Despite their utility, they are insufficient for reliably stratifying rupture risk, underestimating it by approximately 30%, which limits their impact in daily practice.
Recent research has identified emerging risk and protective factors, such as sleep apnea syndrome, lipid control, and the use of antidiabetic, lipid-lowering, or antihypertensive treatments. Therefore, it is necessary to revisit IA rupture risk by considering these factors in relation to patients' living environments.
Social determinants of health (SDOH) play a critical role in this context. Defined as the conditions of life that influence individual and population health, SDOH include broad factors such as age, ethnicity, and gender, as well as addiction behaviors, income levels, environmental exposure, and social status. They are estimated to contribute to over 80% of the population's health outcomes. In vascular diseases, SDOH -such as low education levels, limited income, social isolation, and low physical activity-are known to impact disease severity beyond traditional risk factors. The WHO estimates that vascular diseases are the leading global cause of mortality, with 17.7 million deaths annually, half of which are preventable. Understanding and addressing SDOH is therefore crucial for public health prevention efforts.
Initial studies on the impact of SDOH on IA rupture are limited, often focusing on individual determinants. A more comprehensive approach to SDH is needed, especially given the lack of consensus guidelines for IA management. Current therapeutic options, while advanced, still carry perioperative morbidity. Multivariable modeling and weighted composite scores can help address the complexity of clinical and environmental factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 aged 18 years or older at the time of their first cerebral imaging report mentioning an intracranial aneurysm (IA);
- •Patients with a confirmed saccular IA based on imaging;
- •Presence of at least one document referencing social determinants of health, lifestyle, habits, or exposure.
排除标准
- •Patients who refuse the reuse of their health data;
- •Patients diagnosed with dominant autosomal polycystic liver-kidney disease, sickle cell disease, mycotic aneurysm, fusiform aneurysm, blister-like aneurysm, Marfan syndrome, or Ehlers-Danlos syndrome.
研究组 & 干预措施
ruptured IA or unruptured IA
ruptured IA or unruptured IA
结局指标
主要结局
Study the interaction between social determinants of health (SDH) and individual factors associated with intracranial aneurysm (IA) rupture using data available in the Nantes University Hospital Data Warehouse (EDS)
时间窗: 18 months
Calculate the Odds Ratios (OR) of explanatory factors related to the rupture outcome variable.
次要结局
- Evaluate the impact of new risk factors on rupture occurrence(18 months)
