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

September 12, 2022 updated by: Francesco Sardanelli, IRCCS Policlinico S. Donato

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milano
      • San Donato Milanese, Milano, Italy, 20097
        • IRCCS Policlinico San Donato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
White matter hyperintensities volume expressed in mm^3
Time Frame: 3 years
Semi-automated quantification performed through ITK-SNAP
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Donato

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 17, 2017

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

March 20, 2018

First Submitted That Met QC Criteria

March 27, 2018

First Posted (ACTUAL)

April 4, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 12, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEUCO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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