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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03487302
Recruitment Status : Recruiting
First Posted : April 4, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Francesco Sardanelli, 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.

Condition or disease Intervention/treatment
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)

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Study Type : Observational
Estimated 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 : October 17, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Group/Cohort Intervention/treatment
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).

CONTROLS Other: Brain MRI
Acquisition of 3D T1-weighted, 3D FLAIR and GRE brain MRI scans




Primary Outcome Measures :
  1. White matter hyperintensities volume expressed in mm^3 [ Time Frame: 3 years ]
    Semi-automated quantification performed through ITK-SNAP



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487302


Contacts
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Contact: Francesco Sardanelli, MD +390252774626 francesco.sardanelli@unimi.it

Locations
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Italy
IRCCS Policlinico San Donato Recruiting
San Donato Milanese, Milano, Italy, 20097
Principal Investigator: Francesco Sardanelli, MD         
Sponsors and Collaborators
IRCCS Policlinico S. Donato
Investigators
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Principal Investigator: Francesco Sardanelli, MD IRCCS Policlinico San Donato
Publications:
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Responsible Party: Francesco Sardanelli, Principal Investigator, IRCCS Policlinico S. Donato
ClinicalTrials.gov Identifier: NCT03487302    
Other Study ID Numbers: LEUCO
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Aging, Premature
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities