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Genetic Profile In Patients With Ruptured and Unruptured Intracranial Aneurysms

Key facts

Who runs it
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Where
Italy1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
252 people, planned
Started
6 Feb 2014
Expected to end
Dec 2027
Type of study
Observational
Record updated
11 February 2026

Who can take part

Age
18 years to 80 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

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Who can take part

  • Adults aged 18 to 80 years, of both sexes
  • Patients diagnosed with ruptured or unruptured saccular intracranial aneurysms (sIA)

Who cannot take part

  • Patients unable to provide informed consent due to language impairment or altered consciousness, in the absence of a legally appointed guardian
  • Patients with non-saccular intracranial aneurysms

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Genetic Profile in Patients With Ruptured and Unruptured Intracranial Aneurysms: Observational Study Aimed at Identifying Genetic Variants Associated With the Risk of Intracranial Aneurysm Rupture
Fit questions
Built from NCT07233915, who can take part
Record updated
11 February 2026