Neurogenetic And Hemodynamic Of Migraine Aura And Pfo
ConditionMigraine With Aura
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Usl di Bologna
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
History of congenital heart disease
Trial population
primary care clinic
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Intervention
Other interventionNeurosonological protocol with continuous Doppler monitoring for microemboli detection, cerebrovascular reactivity and dynamic cerebral autoregulation testing, and a contrast-enhanced shunt study using agitated saline; blood samples for whole-exome sequencing and platelet aggregation studies.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Arm 11 intervention
Group B: Arm 21 intervention
Trial outcomes
Primary outcomes
1
Comparison of number of NOTCH3 genetic variants
To evaluate whether significant differences exist in the frequency of NOTCH3 genetic variants between patients with migraine with aura who have a patent foramen ovale (PFO+) and those without (PFO-). Min=0, max undefined.
Time frame
T0 (day 1)Secondary outcomes
1
Comparison of number of genetic variants in other selected genes
To evaluate whether significant differences exist in the frequency of genetic variants in other selected genes between patients with migraine with aura who have a patent foramen ovale (PFO+) and those without (PFO-). Min=0, max undefined.
Time frame
T0 (day 1)2
Correlation of genetic variants with shunt size
To assess whether the frequency of detected variants and SNPs correlates with the size of the right-to-left shunt in the PFO+ group (present vs absent).
Time frame
T0 (day 1)3
Comparison in number of spontaneous microeboli
To evaluate differences in the number of cerebral microemboli between PFO+ and PFO- patients. Min=0, max undefined.
Time frame
T0 (day 1)4
Comparison in cerebrovascular reactivity between PFO+ and PFO- patients
Evaluation of phase shift, gain and coherence for very low, low and high frequency obtained from Transfer function analysis (significant group difference: yes vs no)
Time frame
T0 (day 1)Sponsors and contacts
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Source ClinicalTrials.gov