NCT04578808 Unruptured Cerebral Aneurysm: Prediction of Evolution
| NCT ID | NCT04578808 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Unruptured Intracranial Aneurysm |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2019-08-19 |
| Primary Completion | 2031-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2019-08-19 with a primary completion date of 2031-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The protocol has many assets. A prospective nationwide recruitment allows for the inclusion of a large cohort of patients with UIA. It will combine accurate clinical phenotyping and comprehensive imaging with CAWE screening. Besides, it will enable to exploit metadata and to explore new pathophysiological pathways of interest by crossing clinical, genetic, biological, and imaging information.
Eligibility Criteria
Inclusion Criteria : * Subject carrying unruptured, asymptomatic and untreated typical IA of bifurcation, measured on conventional imaging (MRI, CTA or DSA) between 3 and 7 mm of larger diameter. * Ability to be followed-up during 3 years decided in consensus multidisciplinary gathering. * Age \> 18 years old. Exclusion Criteria : * A failure to obtain informed consent * Contraindications for undergoing an MRI scan include : (heart pacemaker, a metallic foreign body (metal sliver) in their eye, or aneurysm clip in their brain, severe claustrophobia) * Contraindications for a gadolinium contrast medium injection (:eGFR below 30 mL/min/1.73 m2, Previous or pre-existing nephrogenic systemic fibrosis, Previous anaphylactic/anaphylactoid reaction to gadolinium containing contrast agent, Acutely deteriorating renal function, Pregnancy and breast-feeding) * A mycotic, fusiform-shaped, or dissecting IA, an IA in relation with an arteriovenous malformation * A family history of polycystic kidney disease, Ehlers-Danlos syndrome, Marfan's syndrom, fibromuscular dysplasia, or Moya Moya disease * Intra-cavernous UIA because the sinus cavernous that is fulfilled with venous blood precluded a reliable assessment of aneurysmal wall enhancement (AWE)
Contact & Investigator
Romain BOURCIER, MD
PRINCIPAL INVESTIGATOR
Nantes University Hospital
Frequently Asked Questions
Who can join the NCT04578808 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Unruptured Intracranial Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04578808 currently recruiting?
Yes, NCT04578808 is actively recruiting participants. Contact the research team at romain.bourcier@chu-nantes.fr for enrollment information.
Where is the NCT04578808 trial being conducted?
This trial is being conducted at Marseille, France, Brest, France, Bordeaux, France, Toulouse, France and 11 additional locations.
Who is sponsoring the NCT04578808 clinical trial?
NCT04578808 is sponsored by Nantes University Hospital. The principal investigator is Romain BOURCIER, MD at Nantes University Hospital. The trial plans to enroll 1,000 participants.