Status:
COMPLETED
White Matter Hyperintensities Burden in Adult Patients With Cyanotic Congenital Heart Disease: a Pilot Study
Lead Sponsor:
IRCCS Policlinico S. Donato
Conditions:
Aging, Premature
Congenital Heart Disease
Eligibility:
All Genders
20+ years
Brief Summary
The study aims at investigating the role of cyanotic congenital heart disease (cCHD) on brain aging. The investigators assume that due to congenital and acquired cardiovascular abnormalities, cCHD pat...
Detailed Description
White matter hyperintensities burden will be quantified through a semi-autamated software (ITK-SNAP)
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 17 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT03487302
Start Date
October 17 2017
End Date
December 31 2021
Last Update
September 13 2022
Active Locations (1)
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1
IRCCS Policlinico San Donato
San Donato Milanese, Milano, Italy, 20097