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

Completed

• Conditions: Congenital Heart Disease; White Matter Hyperintensities; Aging, Premature
• Interventions: Other: Brain MRI; Other: Neuropsychological test battery

• Registration Number: NCT03487302
• Lead Sponsor: IRCCS Policlinico S. Donato

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.

Detailed Description

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

Study Timeline

• Study Start: 2017-10-17
• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-04-04
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CONTROLS	Brain MRI	-
cCHD	Brain MRI	-
cCHD	Neuropsychological test battery	-

Primary Outcome Measures

Name	Time	Method
White matter hyperintensities volume expressed in mm^3	3 years	Semi-automated quantification performed through ITK-SNAP

Trial Locations

Locations (1)

IRCCS Policlinico San Donato; 🇮🇹 San Donato Milanese, Milano, Italy