Risk Analysis of Intracranial Aneurysm Rupture Through Social Determinants of Health

NCT06866210 | Active Not Recruiting

• 2 other identifiers: RC24_0009DAtAE-2023-5
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Social Determinant of Health; Intracranial Aneurysms; Subarachnoid Hemorrhage; Treatment Outcomes; Natural Languages Processing; Observational Study; Aneurysm, Ruptured

Keywords

Social Determinant of health; Intracranial aneurysm; Subarachnoid hemorrhage; Treatment Outcomes; Natural languages processing; Observational study; Epidemiology; Data warehouse

Outcome Measures

Primary Outcomes (1)

• 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)

  Calculate the Odds Ratios (OR) of explanatory factors related to the rupture outcome variable.

  18 months

Secondary Outcomes (1)

• Evaluate the impact of new risk factors on rupture occurrence

  18 months

Study Arms (1)

ruptured IA or unruptured IA

ruptured IA or unruptured IA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of Nantes Hospital aged 18 years or older at the time of their first cerebral imaging report mentioning an intracranial aneurysm (IA); with a confirmed saccular IA based on imaging.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes Hospital

Nantes, France, 44000, France

Location

MeSH Terms

Conditions

Intracranial Aneurysm; Subarachnoid Hemorrhage; Aneurysm, Ruptured

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: October 15, 2024
• Primary Completion: October 15, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-03

Locations

FR (1)