Last updated: February 6, 2024
Sponsor: Centro Cardiologico Monzino
Overall Status: Active - Recruiting
Phase
N/A
Condition
Migraine (Pediatric)
Chronic Pain
Acute Pain
Treatment
blood samples collection
Clinical Study ID
NCT06046508
CCM 1934
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- presence of PFO with right-left shunt at baseline > 10 MES and during Valsalva > 20MES
- previous Stroke or TIA
- positive MRI for ischemic outcomes
- SIA aneurysm or residual Chiari/Eustachian valve network
- thrombophilic screening positivity (MTHFR/prot C/prot S)
- cability to sign informed consent for study participation and adherence to plannedclinical follow-ups
Exclusion
Exclusion Criteria:
- paroxysmal/refractory atrial fibrillation
- TSA vasculopathy
- left ventricular ejection fraction <30%
- moderate/severe mitral valve regurgitation
- need for long-term anticoagulant therapy
- allergy or intolerance to antiplatelet therapy
- nickel allergy
- severe chronic kidney disease (GFR < 30 mL/min)
Study Design
Total Participants: 120
Treatment Group(s): 1
Primary Treatment: blood samples collection
Phase:
Study Start date:
May 18, 2023
Estimated Completion Date:
April 30, 2025
Study Description
Connect with a study center
IRCCS Policlinico San Donato
San Donato Milanese, Milan 20097
ItalyActive - Recruiting
Università di Cagliari
Cagliari, 09124
ItalySite Not Available
Azienda Ospedaliera Universitaria "Federico II"
Napoli, 80131
ItalySite Not Available
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