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

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.

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Key information

Conditions

Aging, Premature Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms White Matter Hyperintensities

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Policlinico San Donato

San Donato Milanese, Milano, 20097, Italy

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Brain MRI

Other

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

Neuropsychological test battery

Other

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).

Primary outcomes

White matter hyperintensities volume expressed in mm^3

Time frame: 3 years

Semi-automated quantification performed through ITK-SNAP

Sponsors and collaborators

Lead sponsor

IRCCS Policlinico S. Donato

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2021
First posted: Apr 4, 2018
Registry last updated: Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed