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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03487302
Enrollment
146
Registered
2018-04-04
Start date
2017-10-17
Completion date
2021-12-31
Last updated
2022-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Premature, Congenital Heart Disease, White Matter Hyperintensities

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

Detailed description

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

Interventions

OTHERBrain MRI

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

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).

Sponsors

IRCCS Policlinico S. Donato
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
White matter hyperintensities volume expressed in mm^33 yearsSemi-automated quantification performed through ITK-SNAP

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026