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Clinical Trials in Italy / NCT07233915
Recruiting Observational

Genetic Profile In Patients With Ruptured and Unruptured Intracranial Aneurysms

NCT07233915 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Phase
Observational
Started
2014-02-06
Last updated
2026-02-11

Condition(s) studied

Aneurism

Study summary

The project will involve multiple units within our Institute (Neurosurgery, Cerebrovascular Diseases, Neurology IV), as well as additional neurosurgical centers across Italy, for the enrollment of patients with saccular intracranial aneurysms (sIA), both ruptured and unruptured. Based on predefined inclusion and exclusion criteria, the recruitment target over a two-year period is 400 patients with sIA (200 ruptured, 200 unruptured) and 200 healthy controls. The study will not alter clinical practice: treatment decisions for unruptured sIA will be made independently by vascular teams according to routine standards.

For each enrolled subject, anonymized clinical data will be collected (age, sex, BMI, lifestyle habits, family history, comorbidities, aneurysmal parameters) to build an integrated database within the Biorepository. Peripheral blood samples will be obtained for genomic analyses, and when available (e.g., during clipping procedures or lumbar puncture), aneurysm wall tissue and/or cerebrospinal fluid (CSF) samples will be collected for expression studies. All materials and data (clinical/genetic) will be coded and stored at the Cryobank of the Fondazione IRCCS Istituto Neurologico Besta.

Genomic analyses: a pathway-based Genome-Wide Association Study (GWAS) is planned.

Phase I: Genotyping of 200 patients (100 with ruptured sIA, 100 with unruptured sIA) and 100 healthy controls, with combined analysis of genetic data and environmental factors related to rupture risk.

Phase II: Validation in an additional cohort of 200 patients (100 ruptured, 100 unruptured) and 100 controls to confirm the associations of identified SNPs.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Adults aged 18 to 80 years, of both sexes * Patients diagnosed with ruptured or unruptured saccular intracranial aneurysms (sIA) Exclusion Criteria: * Patients with non-saccular intracranial aneurysms * Patients unable to provide informed consent due to language impairment or altered consciousness, in the absence of a legally appointed guardian

Primary outcome measure(s)

  • Identification of genetic variants — Within 2 years from patient enrollment and genotyping (Phase I and Phase II).
    Identification of genetic variants associated with the risk of rupture in patients with saccular intracranial aneurysms (sIA), through a pathway-based genome-wide association study (GWAS).

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Istituto Neurologico Carlo Besta Milan MI Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07233915 on ClinicalTrials.gov ↗ ← All trials in Italy