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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03487302
Other study ID # LEUCO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 17, 2017
Est. completion date December 31, 2021

Study information

Verified date September 2022
Source IRCCS Policlinico S. Donato
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 146
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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).

Study Design


Intervention

Other:
Brain MRI
Acquisition of 3D T1-weighted, 3D FLAIR and GRE brain MRI scans
Neuropsychological test battery
Mini Mental State Examination (MMSE), Measso et al. (1993); Frontal Assessment Battery (FAB), Appollonio et al. (2005); Symbol Digit Test, Amodio et al. (2002); Digit Cancellation Test, Della Sala et al. (1992); Trial Making Test (TMT A-B), Giovagnoli et al. (1996); Weigl's Sorting Test, Laicona et al. (2000) and Inzaghi (2010); Digit Span, Orsini et al (1987); Corsi block-tapping test, Orsini et al. (1987); Babcock story recall test, Carlesimo et al. (2002); Phonemic verbal fluency in MDB, Caltagirone and Carlesimo (2010); Semantic verbal fluency, Novelli (1986); Imitating gestures, De Renzi et al. (1980); Coloured Progressive Matrices (CPM47), Measso et al. (1993).

Locations

Country Name City State
Italy IRCCS Policlinico San Donato San Donato Milanese Milano

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Yushkevich PA, Piven J, Hazlett HC, Smith RG, Ho S, Gee JC, Gerig G. User-guided 3D active contour segmentation of anatomical structures: significantly improved efficiency and reliability. Neuroimage. 2006 Jul 1;31(3):1116-28. Epub 2006 Mar 20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary White matter hyperintensities volume expressed in mm^3 Semi-automated quantification performed through ITK-SNAP 3 years
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