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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-17

Study Completion Date

2021-12-31

Brief Summary

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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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Detailed Description

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

Conditions

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Aging, Premature Congenital Heart Disease White Matter Hyperintensities

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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cCHD

Brain MRI

Intervention Type OTHER

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

Neuropsychological test battery

Intervention Type OTHER

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).

CONTROLS

Brain MRI

Intervention Type OTHER

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

Interventions

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Brain MRI

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

Intervention Type OTHER

Neuropsychological test battery

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).

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes