Neurogenetic And Hemodynamic Of Migraine Aura And Pfo
Recruiting now
Conditions studied: Migraine With Aura
In brief
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.
Key facts
- Study ID
- NCT07349004
- Run by
- Azienda Usl di Bologna
- People needed
- 240
- Starts
- 2025-11-24
- Expected to finish
- 2028-11-01
- Last updated by the study team
- 2026-02-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- History of congenital heart disease
Where it is running
- IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna — Bologna, BO, Italy (enrolling)
Full record on ClinicalTrials.gov
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