Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-01 @ 9:41 AM
Study NCT ID:
NCT03986957
Status:
UNKNOWN
Last Update Posted:
2022-01-04
First Post:
2019-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Approaches of Advanced Neuroimaging Based on MRI Fiber Tracking to Detect Early Signs of Vascular Cognitive Impairment in Hypertensive Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood and urine for biochemical analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 176}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-12-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-03', 'studyFirstSubmitDate': '2019-06-10', 'studyFirstSubmitQcDate': '2019-06-13', 'lastUpdatePostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of percentage change in diffusion parameters of the white matter', 'timeFrame': 'At Enrollment; at 1 year Follow-up', 'description': 'Fiber tracking by DTI MRI'}], 'secondaryOutcomes': [{'measure': 'Detection of cognitive decline by decrease of MoCA score', 'timeFrame': 'At Enrollment; at 1 year Follow-up', 'description': 'Cognitive tests'}, {'measure': 'Characterization of cardiac hypertensive organ damage progression', 'timeFrame': 'At Enrollment; at 1 year Follow-up', 'description': 'Echography'}, {'measure': 'Characterization of renal hypertensive organ damage progression', 'timeFrame': 'At Enrollment; at 1 year Follow-up', 'description': 'eGFR'}, {'measure': 'Characterization of Blood Pressure Variability', 'timeFrame': 'At Enrollment; at 1 year Follow-up', 'description': '24h registration of systolic and diastolic blood pressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vascular Cognitive Impairment', 'Magnetic Resonance Imaging', 'Blood Pressure Variability'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'Hypertension is the major risk factor for vascular cognitive impairment (VCI). One of the main limitations in the clinical approach to VCI is that, by the time that it is manifested, it might be too late to reverse the neurodegenerative process. Thus, early identification of predictive signs of later dementia is demanding for management of hypertensive patients (HT).This aim claims for new methods that compute in a cloud all possible data sources coming from patients (brain imaging, cognitive profile, clinical data), to extract discriminative aggregate biomarkers. Thus, this study aims at: 1) characterizing the predictive potential of an aggregate biomarker for dementia in HT, based on brain imaging, clinical and cognitive assessment; 2) evaluating the impact of blood pressure variability, besides systolic/diastolic blood pressure, on the progression of the aggregate biomarker; 3) assessing whether specific classes of antihypertensive drugs differently affect the progression of the aggregate biomarker. In order to do this, this study proposes to evaluate advanced brain imaging and cognitive profile in a cohort of hypertensive patients, at baseline and after a 1 year follow up, to identify an innovative signature for the development of cognitive dysfunction in hypertension. In particular, the effects of blood pressure variability and of different classes of antihypertensive drugs will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be selected from patients attending the Department of AngioCardioNeurology of the IRCCS Neuromed, accordingly to the following inclusion/exclusion criteria. Approximately 176 subjects of both genders will be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 40 and ≤ 70 years\n* patients with moderate hypertension\n* written informed consent\n\nExclusion Criteria:\n\n* previous IMA, stroke or TIA\n* arrhythmia or severe cardiac disease\n* Diabetes or renal disease\n* psychiatric disease\n* neurological or neurodegenerative disease\n* dementia\n* assumption of drugs known to interfere with cognitive function\n* inability to be subjected MRI analysis\n* participation to other clinical trial, ongoing or terminated less than one month before enrolment in this study.'}, 'identificationModule': {'nctId': 'NCT03986957', 'briefTitle': 'Novel Approaches of Advanced Neuroimaging Based on MRI Fiber Tracking to Detect Early Signs of Vascular Cognitive Impairment in Hypertensive Patients', 'organization': {'class': 'OTHER', 'fullName': 'Neuromed IRCCS'}, 'officialTitle': 'Novel Approaches of Advanced Neuroimaging Based on MRI Fiber Tracking to Detect Early Signs of Vascular Cognitive Impairment in Hypertensive Patients', 'orgStudyIdInfo': {'id': 'LMB07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypertensive patients', 'description': 'Patients with SBP: 140-159; DBP: 90-99', 'interventionNames': ['Other: No interventions']}], 'interventions': [{'name': 'No interventions', 'type': 'OTHER', 'description': 'No interventions - observational study', 'armGroupLabels': ['Hypertensive patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86077', 'city': 'Pozzilli', 'state': 'Isernia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Lembo, MD, PhD', 'role': 'CONTACT', 'email': 'lembo@neuromed.it', 'phone': '+39 0865.915225'}, {'name': 'Giuseppe Lembo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lorenzo Carnevale, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'IRCCS Neuromed', 'geoPoint': {'lat': 41.51142, 'lon': 14.06252}}], 'centralContacts': [{'name': 'Giuseppe Lembo, MD, PhD', 'role': 'CONTACT', 'email': 'lembo@neuromed.it', 'phone': '+390865915225'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neuromed IRCCS', 'class': 'OTHER'}, 'collaborators': [{'name': 'IRCCS Multimedica', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor, MD, PhD', 'investigatorFullName': 'Giuseppe Lembo', 'investigatorAffiliation': 'Neuromed IRCCS'}}}}