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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT03487302
Eligibility Criteria:
Inclusion Criteria:
* for the patient group, being an adult subject affected with cyanotic congenital heart disease, whether surgically corrected or not.
* for the control group, being an healthy subject.
Exclusion Criteria:
* any contraindication to magnetic resonance imaging;
* any pathological condition and/or symptomp that could alter the white matter hyperintensities burden, among which:
* inflammatory, infectious, demyelinating or dysmyelinating diseases of the CNS;
* ischemic, haemorrhagic or traumatic brain events and eventual gliotic and malacic or lacunar sequelae;
* genetic diseases (whether mendelian or mitochondrial) of the CNS;
* cerebral amyloid angiopathy;
* CADASIL;
* cerebral arteriovenous malformations;
* primary or metastatic brain neoplasms which cause neurological symptoms and/or brain parenchymal sequelae from surgical excision;
* patent oval foramen;
* being pregnant;
* migraine with aura (Bashir, Lipton, Ashina, \& Ashina, 2013).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT03487302
Study Brief:
Protocol Section:
NCT03487302