Actively Recruiting

Age: 18Years +
All Genders
ID07349004

Association Between Patent Foramen Ovale and Migraine With Aura: A Case-Control Observational Study Using Genetic and Neurosonological Analysis

Led by Azienda Usl di Bologna · Updated on 2026-02-11

240

Participants Needed

1

Research Sites

153 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are exploring the relationship between patent foramen ovale (PFO) and migraine with aura (MA) in adults diagnosed with MA according to recognized criteria. This observational study aims to understand genetic differences, especially in the NOTCH3 gene and other related genes, between patients with and without PFO, and to investigate how these differences may relate to vascular and platelet function. The study seeks to provide insights into the biological mechanisms linking PFO and MA, which may influence future prevention and treatment strategies. Participants are classified into two groups: those with MA and PFO and those with MA without PFO. Each participant undergoes a single study visit including a detailed clinical and demographic assessment, neurosonological tests such as continuous Doppler monitoring for microembolic signals, cerebrovascular reactivity tests using breath-hold and hyperventilation, and contrast-enhanced shunt detection using agitated saline. Blood samples are collected for whole-exome sequencing focusing on selected genes and for platelet aggregation studies. During the visit, data on migraine characteristics and brain MRI findings are gathered when available. The study measures genetic variants, microembolic signals, cerebrovascular reactivity, cerebral autoregulation, and platelet function to analyze differences between groups. The study plans to enroll 240 adult participants over 36 months, aiming to clarify the biological differences between those with and without PFO and MA.

CONDITIONS

Brief Title

Neurogenetic And Hemodynamic Of Migraine Aura And Pfo

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of migraine with aura according to International Classification of Headache Disorders, 3rd edition (ICHD-3)
  • Age 18 years or older
  • Both sexes
  • Written informed consent obtained to participate in the study
Not Eligible

You will not qualify if you...

  • History of congenital heart disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo a single study visit involving neurosonological assessments including continuous transcranial Doppler monitoring, cerebrovascular reactivity testing, dynamic cerebral autoregulation evaluation, and contrast-enhanced shunt study using agitated saline. Blood samples are collected for genetic analysis and platelet function testing.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna

Bologna, BO, Italy, 40139

Actively Recruiting

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Research Team

M

Matteo Paolucci

A

Andrea Zini

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Migraine in Patients Undergoing PFO Closure: Characterization of a Platelet-Associated Pathophysiological Mechanism: The LEARNER Study.

Daniela Trabattoni, Marta Brambilla, Paola Canzano...

https://pubmed.ncbi.nlm.nih.gov/35818509

A meta-analysis of case-control studies of the association of migraine and patent foramen ovale.

Hisato Takagi, Takuya Umemoto, ALICE (All-Literature Investigation of Cardiovascular Evidence) Group

https://pubmed.ncbi.nlm.nih.gov/26527111

Genetic variants of the NOTCH3 gene in the elderly and magnetic resonance imaging correlates of age-related cerebral small vessel disease.

Helena Schmidt, Marion Zeginigg, Marco Wiltgen...

https://pubmed.ncbi.nlm.nih.gov/22006983

The Role of Endothelial Dysfunction in the Pathophysiology and Cerebrovascular Effects of Migraine: A Narrative Review.

Matteo Paolucci, Claudia Altamura, Fabrizio Vernieri

https://pubmed.ncbi.nlm.nih.gov/33835736