Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-02 @ 11:32 AM
Study NCT ID:
NCT05773235
Status:
UNKNOWN
Last Update Posted:
2023-03-17
First Post:
2023-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI-markers to Monitor Small Vessel Disease Dynamics in the Prognosis of Small Vessel Disease-associated, Cerebrovascular Events
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D028243', 'term': 'Cerebral Amyloid Angiopathy, Familial'}, {'id': 'D059345', 'term': 'Cerebral Small Vessel Diseases'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D016657', 'term': 'Cerebral Amyloid Angiopathy'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020739', 'term': 'Brain Diseases, Metabolic, Inborn'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D002539', 'term': 'Cerebral Arterial Diseases'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D028226', 'term': 'Amyloidosis, Familial'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000686', 'term': 'Amyloidosis'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D020521', 'term': 'Stroke'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-06', 'studyFirstSubmitDate': '2023-02-09', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease progression', 'timeFrame': '24 months', 'description': 'Composite endpoint of a new, clinically symptomatic ischaemic or haemorrhagic event as defined by the treating physician and/or any increase in small vessel disease and/or cerebral amyloid angiopathy burden according to small vessel disease burden score (range 0-4 points, higher score means higher small vessel disease burden) or cerebral amyloid angiopathy burden score (range 0-6 points, higher score means higher cerebral amyloid angiopathy burden), respectively.'}], 'secondaryOutcomes': [{'measure': 'MRI-defined disease progression', 'timeFrame': '24 months', 'description': 'Any increase in small vessel disease (SVD) and/or cerebral amyloid angiopathy (CAA) burden according to small vessel disease burden score (range 0-4 points, higher score means higher small vessel disease burden) or cerebral amyloid angiopathy burden score (range 0-6 points, higher score means higher cerebral amyloid angiopathy burden), respectively.'}, {'measure': 'Increase in number of SVD-attributable, ischaemic lesions', 'timeFrame': '24 months', 'description': 'Composite outcome defined as any increase in numeric count for lacunes and/or increase in perivascular space severity scale (0/1-10 PVS/11-20 PVS/21-40 PVS/\\>40 PVS) and/or increase in periventricular or deep separate white matter Fazekas scale.'}, {'measure': 'Increase in number of SVD-attributable, haemorrhagic lesions', 'timeFrame': '24 months', 'description': 'Composite outcome defined as any increase in numeric count for cerebral microbleeds and/or increase in cortical superficial siderosis multifocality score.'}, {'measure': 'Increase in perivascular space severity scale', 'timeFrame': '24 months', 'description': 'Defined as any increase in perivascular space (PVS) severity scale (0/1-10 PVS/11-20 PVS/21-40 PVS/\\>40 PVS, higher number of PVS means higher small vessel disease burden).'}, {'measure': 'Clinical, vascular outcome event', 'timeFrame': '24 months', 'description': 'Composite endpoint including any of the following, clinically apparent events:\n\n* ischaemic stroke as diagnosed by CT or MRI and causing a corresponding clinical deficit (as assessed by the treating physician)\n* intracerebral haemorrhage as diagnosed by CT or MRI and causing a corresponding clinical deficit (as assessed by the treating physician)\n* systemic vascular event defined as radiological or clinical evidence of arterial hypoperfusion and judged by the treating physician to be due to an atherosclerotic or embolic cause.'}, {'measure': 'Functional outcome', 'timeFrame': '24 months', 'description': 'Modified Rankin Scale (ordinal scale, range 0-6 with 0 corresponding to no symptoms at all and 6 corresponding to death).'}, {'measure': 'New cognitive impairment', 'timeFrame': '24 months', 'description': 'Montreal Cognitive Assessment (MoCA, range 0-30 points) \\< 26 points (corresponding to impaired cognitive function) and/or new impairment in activities of daily living as defined by the treating physician .'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intracerebral hemorrhage', 'Ischemic stroke', 'Cerebral amyloid angiopathy', 'Hypertensive deep perforator arteriopathy', '7 Tesla-MRI', 'Cerebral small vessel disease', 'Ultra high-field MRI'], 'conditions': ['Intracerebral Hemorrhage', 'CAA - Cerebral Amyloid Angiopathy', 'Cerebral Small Vessel Diseases']}, 'descriptionModule': {'briefSummary': 'This is a nested cohort study in the PRO-SVD cohort. Small vessel disease is a chronic disease and is thought to progress over time. MRI is the gold standard to diagnose small vessel disease, but data on MRI-visible disease progression are scarce. Complications of small vessel disease as well as location pattern, distribution and severity of these MRI small vessel disease markers differ according to the underlying phenotype. The primary aim of this project is to investigate individual small vessel disease burden progression detected by MRI in survivors or intracerebral hemorrhage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '50 consecutive patients with cerebral small vessel disease-related intracerebral hemorrhage admitted to the Inselspital Bern. Patients will undergo combined 3/7 Tesla-MRI according to a standardised small vessel disease MRI protocol at 3 timepoints.\n\nA control group consisting of 10 clinically asymptomatic subjects will undergo the same MRI protocol at one timepoint.', 'healthyVolunteers': True, 'eligibilityCriteria': 'For patients with intracerebral hemorrhage\n\nInclusion Criteria:\n\n* Patient participating in the PRO-SVD cohort\n* Symptomatic intracranial hemorrhage\n* Written informed consent provided by patient or next-of-kin\n* No contraindications against MRI\n\nExclusion Criteria:\n\n* Patient unsuitable for MRI follow-ups (e.g. claustrophobia)\n* Patients unlikely to attend 1-year follow-up\n\nFor healthy controls\n\nInclusion Criteria:\n\n* Clinically healthy person ≥ 55 years\n* Written informed consent provided by the healthy control\n* No contraindications against MRI\n\nExclusion Criteria:\n\n* Known or suspected cerebral small vessel diseases or presence of concurrent diseases potentially mimicking small vessel disease (e.g. multiple sclerosis, previous heart surgery etc.)\n* Pre-existing dementia, cognitive decline or disorder of the central nervous system.'}, 'identificationModule': {'nctId': 'NCT05773235', 'acronym': 'MRI-PRO-SVD', 'briefTitle': 'MRI-markers to Monitor Small Vessel Disease Dynamics in the Prognosis of Small Vessel Disease-associated, Cerebrovascular Events', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'MRI-markers to Monitor Small Vessel Disease Dynamics in the Prognosis of Small Vessel Disease-associated, Cerebrovascular Events - a Prospective Cohort Study', 'orgStudyIdInfo': {'id': '2021-02006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with intracerebral hemorrhage', 'description': 'Patients with symptomatic intracranial hemorrhage (defined as non-traumatic intracerebral hemorrhage or convexity, non-aneurysmal subarachnoid hemorrhage) enrolled in the PRO-SVD study', 'interventionNames': ['Diagnostic Test: Combined 3- and 7 Tesla-MRI']}, {'label': 'Healthy controls', 'description': 'Clinically healthy persons of at least 55 years of age', 'interventionNames': ['Diagnostic Test: Combined 3- and 7 Tesla-MRI']}], 'interventions': [{'name': 'Combined 3- and 7 Tesla-MRI', 'type': 'DIAGNOSTIC_TEST', 'description': '7 Tesla-MRI including the following sequences: susceptibility weighted imaging (SWI), T1, T2, FLAIR, quantitative mapping sequences (T1mapping, qSM)', 'armGroupLabels': ['Healthy controls', 'Patients with intracerebral hemorrhage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'David J Seiffge, MD, Prof', 'role': 'CONTACT', 'email': 'david.seiffge@insel.ch', 'phone': '+41 31 632 70 00'}, {'name': 'Martina B Goeldlin, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Neurology, Inselspital Bern University Hospital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'centralContacts': [{'name': 'Marianne Kormann', 'role': 'CONTACT', 'email': 'studien.stroke@insel.ch', 'phone': '+41 31 632 70 00'}], 'overallOfficials': [{'name': 'David J Seiffge, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, Inselspital Bern University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data sharing can be discussed by qualified researchers with the principal investigator upon reasonable request and might be subject to prior additional approval by the respective ethical board.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}