Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT03521193
Eligibility Criteria:
Inclusion Criteria:
* Patients older than 18 years with more than 2 criteria:
* Previous Stroke or TIA (transient ischemic attack)
* positive MRI for ischemic events -
* PFO with a baseline R-L shunt \> 10 microembolic signals (MES) and \> 20 MES during/after Valsalva Manoeuver
* Atrial septal aneurysm (ASA) or residual Chiari network or Eustachian Valve
* positive Thrombophilic screening (MTHFR/prot C/Prot S)
* Ability to sign the informed consent for the study participation
Exclusion Criteria:
* Patients older than 70 years
* Paroxysmal Atrial fibrillation
* Carotid, vertebral or basilar artery stenosis\> 50% on duplex imaging
* Inadequate temporal bone windows (signals) for transcranial Doppler insonation
* medication overuse headache
* history of cognitive dysfunction, epilepsy, brain injury
* use of continuous positive airway pressure (CPAP) within 6 months of study enrollment
* Left Ventricular Ejection Fraction (LVEF) \< 30%
* Moderate/severe mitral valve regurgitation
* Known Allergy to aspirin
* Known allergy to nickel
* Severe chronic kidney disease (GFR \< 30 ml/min)
* Beck depression inventory score \> or= 29
* State-trait anxiety inventory score exceeding cut-off for are and sex
Keywords: PFO, migraine, migraine with aura, aura, platelets
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03521193
Study Brief:
Protocol Section:
NCT03521193