Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT03487302
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2018-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
White Matter Hyperintensities Burden in Adult Patients With Cyanotic Congenital Heart Disease: a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019588', 'term': 'Aging, Premature'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-12', 'studyFirstSubmitDate': '2018-03-20', 'studyFirstSubmitQcDate': '2018-03-27', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'White matter hyperintensities volume expressed in mm^3', 'timeFrame': '3 years', 'description': 'Semi-automated quantification performed through ITK-SNAP'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging, Premature', 'Congenital Heart Disease', 'White Matter Hyperintensities']}, 'referencesModule': {'references': [{'pmid': '16545965', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1016/j.neuroimage.2006.01.015. Epub 2006 Mar 20.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'White matter hyperintensities burden will be quantified through a semi-autamated software (ITK-SNAP)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* for the patient group, being an adult subject affected with cyanotic congenital heart disease, whether surgically corrected or not;\n* for the control group, being an healthy subject.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* for the patient group, being an adult subject affected with cyanotic congenital heart disease, whether surgically corrected or not.\n* for the control group, being an healthy subject.\n\nExclusion Criteria:\n\n* any contraindication to magnetic resonance imaging;\n* any pathological condition and/or symptomp that could alter the white matter hyperintensities burden, among which:\n\n * inflammatory, infectious, demyelinating or dysmyelinating diseases of the CNS;\n * ischemic, haemorrhagic or traumatic brain events and eventual gliotic and malacic or lacunar sequelae;\n * genetic diseases (whether mendelian or mitochondrial) of the CNS;\n * cerebral amyloid angiopathy;\n * CADASIL;\n * cerebral arteriovenous malformations;\n * primary or metastatic brain neoplasms which cause neurological symptoms and/or brain parenchymal sequelae from surgical excision;\n * patent oval foramen;\n * being pregnant;\n * migraine with aura (Bashir, Lipton, Ashina, \\& Ashina, 2013).'}, 'identificationModule': {'nctId': 'NCT03487302', 'briefTitle': 'White Matter Hyperintensities Burden in Adult Patients With Cyanotic Congenital Heart Disease: a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Policlinico S. Donato'}, 'officialTitle': 'Assessment of White Matter Hyperintensities Burden in Adult Patients With Cyanotic Congenital Heart Disease: a Pilot Study', 'orgStudyIdInfo': {'id': 'LEUCO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cCHD', 'interventionNames': ['Other: Brain MRI', 'Other: Neuropsychological test battery']}, {'label': 'CONTROLS', 'interventionNames': ['Other: Brain MRI']}], 'interventions': [{'name': 'Brain MRI', 'type': 'OTHER', 'description': 'Acquisition of 3D T1-weighted, 3D FLAIR and GRE brain MRI scans', 'armGroupLabels': ['CONTROLS', 'cCHD']}, {'name': 'Neuropsychological test battery', 'type': 'OTHER', 'description': "1. Mini Mental State Examination (MMSE), Measso et al. (1993);\n2. Frontal Assessment Battery (FAB), Appollonio et al. (2005);\n3. Symbol Digit Test, Amodio et al. (2002);\n4. Digit Cancellation Test, Della Sala et al. (1992);\n5. Trial Making Test (TMT A-B), Giovagnoli et al. (1996);\n6. Weigl's Sorting Test, Laicona et al. (2000) and Inzaghi (2010);\n7. Digit Span, Orsini et al (1987);\n8. Corsi block-tapping test, Orsini et al. (1987);\n9. Babcock story recall test, Carlesimo et al. (2002);\n10. Phonemic verbal fluency in MDB, Caltagirone and Carlesimo (2010);\n11. Semantic verbal fluency, Novelli (1986);\n12. Imitating gestures, De Renzi et al. (1980);\n13. Coloured Progressive Matrices (CPM47), Measso et al. (1993).", 'armGroupLabels': ['cCHD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20097', 'city': 'San Donato Milanese', 'state': 'Milano', 'country': 'Italy', 'facility': 'IRCCS Policlinico San Donato', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}], 'overallOfficials': [{'name': 'Francesco Sardanelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Policlinico S. Donato'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Policlinico S. Donato', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Francesco Sardanelli', 'investigatorAffiliation': 'IRCCS Policlinico S. Donato'}}}}