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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487302
• Other study ID #: LEUCO
• Status: Completed
• 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
• 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).

Related Conditions & MeSH terms

• Aging, Premature
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• White Matter Hyperintensities

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