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

Sponsor

IRCCS Policlinico S. Donato (Other)

Overall Status

Unknown status

CT.gov ID

NCT03487302

Collaborator

(none)

146

Enrollment

Location

38.5

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Aging, Premature Congenital Heart Disease White Matter Hyperintensities	Other: Brain MRI Other: Neuropsychological test battery

Detailed Description

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

146 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Oct 17, 2017

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
cCHD	Other: Brain MRI Acquisition of 3D T1-weighted, 3D FLAIR and GRE brain MRI scans Other: 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).
CONTROLS	Other: Brain MRI Acquisition of 3D T1-weighted, 3D FLAIR and GRE brain MRI scans

Arm

Intervention/Treatment

cCHD

Other: Brain MRI

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

Other: 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).

CONTROLS

Other: Brain MRI

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

Outcome Measures

Primary Outcome Measures

White matter hyperintensities volume expressed in mm^3 [3 years]
Semi-automated quantification performed through ITK-SNAP

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Policlinico San Donato	San Donato Milanese	Milano	Italy	20097

Sponsors and Collaborators

IRCCS Policlinico S. Donato

Investigators

Principal Investigator: Francesco Sardanelli, MD, IRCCS Policlinico San Donato

Study Documents (Full-Text)

None provided.

More Information

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. Epub 2006 Mar 20.

Responsible Party:

Francesco Sardanelli, Principal Investigator, IRCCS Policlinico S. Donato

ClinicalTrials.gov Identifier:

NCT03487302

Other Study ID Numbers:

LEUCO

First Posted:

Apr 4, 2018

Last Update Posted:

Apr 5, 2018

Last Verified:

Apr 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Diseases

Heart Defects, Congenital

Aging, Premature

Study Results

No Results Posted as of Apr 5, 2018