White Matter Hyperintensities Burden in Adult Patients With Cyanotic Congenital Heart Disease: a Pilot Study

IRCCS Policlinico S. Donato146 enrolled

Overview

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 patients could show radiologic (and clinical) signs of precocious brain aging and eventual cognitive decline.

White matter hyperintensities burden will be quantified through a semi-autamated software (ITK-SNAP)

Study Type

OBSERVATIONAL

Enrollment

146

Conditions

Aging, Premature Congenital Heart Disease White Matter Hyperintensities

Interventions

Brain MRIOTHER

Acquisition of 3D T1-weighted, 3D FLAIR and GRE brain MRI scans

Neuropsychological test batteryOTHER

1. Mini Mental State Examination (MMSE), Measso et al. (1993); 2. Frontal Assessment Battery (FAB), Appollonio et al. (2005); 3. Symbol Digit Test, Amodio et al. (2002); 4. Digit Cancellation Test, Della Sala et al. (1992); 5. Trial Making Test (TMT A-B), Giovagnoli et al. (1996); 6. Weigl's Sorting Test, Laicona et al. (2000) and Inzaghi (2010); 7. Digit Span, Orsini et al (1987); 8. Corsi block-tapping test, Orsini et al. (1987); 9. Babcock story recall test, Carlesimo et al. (2002); 10. Phonemic verbal fluency in MDB, Caltagirone and Carlesimo (2010); 11. Semantic verbal fluency, Novelli (1986); 12. Imitating gestures, De Renzi et al. (1980); 13. Coloured Progressive Matrices (CPM47), Measso et al. (1993).

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milano, Italy

Outcomes

Primary Outcomes

White matter hyperintensities volume expressed in mm^3

Semi-automated quantification performed through ITK-SNAP

Time frame: 3 years

Data from ClinicalTrials.gov

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