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CompletedNCT03487302Updated Sep 13, 2022

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

An observational study in Aging, Premature, Congenital Heart Disease and White Matter Hyperintensities, sponsored by IRCCS Policlinico S. Donato. Completed at 1 site in Italy. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-13.

Sponsored by IRCCS Policlinico S. Donato · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
146
Ages
20 Years and older
Sex
All
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Study 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.

Read the detailed description

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

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Conditions studied

  • Aging, Premature
  • Congenital Heart Disease
  • White Matter Hyperintensities
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In context

Heart Defects, Congenital

1,031 studies on the registry are indexed under Heart Defects, Congenital; 262 are open to participants now.

This study's enrollment of 146 is above the median of 120 across 459 observational studies indexed under Heart Defects, Congenital.

Browse Heart Defects, Congenital studies →

Lead sponsor

IRCCS Policlinico S. Donato is the lead sponsor of 103 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

  • 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
146 participants (actual)
Patient registry
No

Groups and cohorts

  • cCHD

    Other: Brain MRI · Other: Neuropsychological test battery

  • CONTROLS

    Other: Brain MRI

Interventions

  • OtherBrain MRI

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

  • OtherNeuropsychological 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).

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What researchers measure

Primary outcomes

  1. White matter hyperintensities volume expressed in mm^3

    Semi-automated quantification performed through ITK-SNAP

    Time frame: 3 years

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Study locations

1 site
  • IRCCS Policlinico San Donato
    San Donato Milanese, Milano 20097, Italy
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References and documents

Publications

  • 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. doi: 10.1016/j.neuroimage.2006.01.015. Epub 2006 Mar 20. PubMed 16545965 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03487302
Responsible party
Francesco Sardanelli (Principal Investigator, IRCCS Policlinico S. Donato) — Principal investigator
First posted
Apr 4, 2018
Start date
Oct 17, 2017
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Sep 13, 2022

Study contacts

Francesco Sardanelli, MD
principal investigator · IRCCS Policlinico S. Donato

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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