NCT07349004 Neurogenetic And Hemodynamic Of Migraine Aura And Pfo
| NCT ID | NCT07349004 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Usl di Bologna |
| Condition | Migraine With Aura |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-11-24 |
| Primary Completion | 2025-11-24 |
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 240 participants in total. It began in 2025-11-24 with a primary completion date of 2025-11-24.
⚠ 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 PFOCUS Study aims to clarify the relationship between patent foramen ovale (PFO) and migraine with aura (MA). Patients diagnosed with MA according to ICHD-3 criteria will be classified as cases (PFO+) or controls (PFO-) based on the presence or absence of a right-to-left shunt detected by transcranial Doppler or a previously documented PFO. The study will enroll 240 adult participants over 36 months. The primary objective is to determine whether genetic variants differ significantly between patients with MA with and without PFO. Secondary objectives include assessing cerebral blood flow regulation and platelet function in patients with MA with and without PFO. Participants will undergo a single study visit including the collection of demographic and clinical data and a comprehensive neurosonological assessment. This will include microembolic signal counts, cerebrovascular reactivity testing, and a contrast-enhanced transcranial Doppler study for shunt detection. Blood samples will be collected for whole-exome sequencing (with a focus on NOTCH3 and an expanded gene panel) and for platelet aggregometry. The study is expected to provide new insights into the biological mechanisms linking PFO and MA-potentially involving endothelial dysfunction, altered vascular smooth muscle responses, or platelet activation-thereby informing prevention strategies and guiding future research.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of migraine with aura (according to Chapter 1.2 of the International Classification of Headache Disorders, 3rd edition \[ICHD-3\]) * Age ≥ 18 years * Both sexes * Obtained written informed consent to participate in the study Exclusion Criteria: * History of congenital heart disease
Contact & Investigator
Matteo Paolucci
PRINCIPAL INVESTIGATOR
IRCCS Istituto delle Scienze Neurologiche di Bologna
Frequently Asked Questions
Who can join the NCT07349004 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Migraine With Aura. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07349004 currently recruiting?
Yes, NCT07349004 is actively recruiting participants. Contact the research team at matteo.paolucci@ausl.bologna.it for enrollment information.
Where is the NCT07349004 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT07349004 clinical trial?
NCT07349004 is sponsored by Azienda Usl di Bologna. The principal investigator is Matteo Paolucci at IRCCS Istituto delle Scienze Neurologiche di Bologna. The trial plans to enroll 240 participants.
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