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Recruiting NCT06935578

NCT06935578 RAre, But Not aLone: a Large Italian Network to Empower the Impervious diaGNostic Pathway of Rare cerEbrovascular Diseases (ALIGNED)

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Clinical Trial Summary
NCT ID NCT06935578
Status Recruiting
Phase
Sponsor Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Condition CADASIL
Study Type OBSERVATIONAL
Enrollment 500 participants
Start Date 2023-05-01
Primary Completion 2026-05-19

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

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 500 participants in total. It began in 2023-05-01 with a primary completion date of 2026-05-19.

⚠ 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

Cerebrovascular diseases (CVDs) are one leading cause of morbidity and mortality worldwide. Despite intensive investigations, more than 30% of strokes remain of undetermined origin. Rare Cerebrovascular Diseases (rCVDs), including heritable (i.e., CADASIL, COL4A1 syndrome, Fabry disease) and acquired conditions (i.e., Sneddon syndrome, Moyamoya arteriopathy) account for a proportion of these strokes. However, rCVDs are often misdiagnosed since clinicians are not able to recognize them. Although rare, the identification of these stroke causes is important to establish appropriate management measures, including genetic counselling, and, if available, therapy. The lack of data on phenotype and clinical course of rCVDs, given the paucity of published series, makes the diagnosis and the development of therapies challenging. Furthermore, the molecular characterization of rCVDs is still lacking, despite progresses achieved in common stroke by applying high throughput approaches as multi-omics. Since the diagnosis and care of rCVDs require adequate expertise and instrumental tools, clinical and research activities are usually reserved to few specialized centers, mostly located in the North of Italy, leading patients to expensive trips for consultations. Therefore, the creation of a clinical and research network aimed at improving the diagnostic pathways of rCVDs is highly needed to improve the number of patients with rCVDs to better define the clinical phenotype and to transfer the knowledge on rCVDs in other centers overall Italy filling the geographical gap affecting Southern Italy.

Eligibility Criteria

Inclusion Criteria: * patients with a clinical, genetic and/or neuroradiological diagnosis of rCVD (CADASIL, Fabry's disease, COL4A1, Sneddon's syndrome or Moyamoya arteriopathy), who have had at least one brain MRI study; Exclusion Criteria: * na

Contact & Investigator

Central Contact

Anna Bersano, MD

✉ anna.bersano@istituto-besta.it

📞 + 39 02.2394

Frequently Asked Questions

Who can join the NCT06935578 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying CADASIL. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06935578 currently recruiting?

Yes, NCT06935578 is actively recruiting participants. Contact the research team at anna.bersano@istituto-besta.it for enrollment information.

Where is the NCT06935578 trial being conducted?

This trial is being conducted at Acquaviva delle Fonti, Italy, Melegnano, Italy, Rho, Italy, Cefalù, Italy and 11 additional locations.

Who is sponsoring the NCT06935578 clinical trial?

NCT06935578 is sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta. The trial plans to enroll 500 participants.

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