Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT06147102
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-10
First Post:
2023-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2023-11-20', 'studyFirstSubmitQcDate': '2023-11-20', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'New ischemic lesion on postoperative MRI', 'timeFrame': '1-3 days', 'description': 'Diffusion-Weighted Imaging lesion'}], 'secondaryOutcomes': [{'measure': 'Neurological symptom', 'timeFrame': '3 months', 'description': 'New procedure-related neurological symptom'}, {'measure': 'Return to work', 'timeFrame': '3 months', 'description': 'Days from intervention to return to work'}, {'measure': 'Functional outcome', 'timeFrame': '3 months', 'description': 'modified Rankin Scale (mRS going from 0 \\[no sympyoms\\] to 6 death\\])'}, {'measure': 'Aneurysm occlusion on angiography', 'timeFrame': '6mo - 5yrs', 'description': 'Rate of occluded vs. incompletely occluded aneurysms. Assessed through digital subtraction angiography, CTA or MRA. Routine controls for endovascularly treated patients 6mo, 2y, and if needed 5y. Routinely assessed by a postoperative CTA for surgically treated patients.'}, {'measure': 'Patients with late rebleeding from the target aneurysm', 'timeFrame': 'up to 10 yrs', 'description': 'Number of patients with rebleeding (subarachnoid hemorrhage \\[SAH\\]) from the treated aneurysm'}, {'measure': 'Epilepsy', 'timeFrame': 'up to 10 yrs', 'description': 'Number of patients with a new diagnosis of epilepsy after aneurysm treatment'}, {'measure': 'Dementia', 'timeFrame': 'up to 10 yrs', 'description': 'Number of patients with a new diagnosis of dementia after aneurysm treatment'}, {'measure': 'Other stroke than aneurysm bleed', 'timeFrame': 'up to 10 yrs', 'description': 'Number of patients with a new stroke (other than SAH from the treated aneurysm) after aneurysm treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intracranial aneurysm', 'surgery', 'neurosurgery', 'endovascular', 'interventional neuroradiology', 'neurointervention', 'unruptured'], 'conditions': ['Intracranial Aneurysm']}, 'referencesModule': {'references': [{'pmid': '41349033', 'type': 'DERIVED', 'citation': 'Raj R, Numminen J, Huhtakangas J, Nurminen V, Lehecka M, Laakso A, Kivipelto L, Niemela M, Korja M. The Helsinki Unruptured Intracranial Aneurysm Quality of Care study: a prospective observational study. J Neurosurg. 2025 Dec 5:1-10. doi: 10.3171/2025.7.JNS25775. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'A research-initiated prospective cohort study with the aim to assess the effectivity, safety and long-term outcomes after surgical and endovascular treatment of unruptured intracranial aneurysms. All consecutive patients with a non-ruptured intracranial aneurysms treated at Helsinki University Hospital will be included. Safety is measured by postoperative magnetic resonance imaging (MRI) taken 1-3 days after the treatment, treatment-related complications and functional outcome at three months. Effectiveness is measured by angiographic results and assessment of long-term bleeding from the treated aneurysm. Other outcomes include risk of developing epilepsy, getting a new stroke, and dementia on long-term follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing endovascular or surgical treatment for an unruptured intracranial aneurysm at Helsinki university hospital', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with an unruptured intracranial aneurysm undergoing treatment\n\nExclusion Criteria:\n\n* Arteriovenous malformation related intracranial aneurysm\n* Moyamoya-disease related intracranial aneurysm\n* Ruptured intracranial aneurysm'}, 'identificationModule': {'nctId': 'NCT06147102', 'acronym': 'HUIQE', 'briefTitle': 'The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'The Helsinki Unruptured Intracranial Aneurysm Quality of Care Study', 'orgStudyIdInfo': {'id': 'HUS/216/2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endovascular treatment', 'description': 'Patients with unruptured intracranial aneurysms treated endovascularly', 'interventionNames': ['Procedure: Endovascular']}, {'label': 'Surgical treatment', 'description': 'Patients with unruptured intracranial aneurysms treated surgically', 'interventionNames': ['Procedure: Surgery']}], 'interventions': [{'name': 'Surgery', 'type': 'PROCEDURE', 'description': 'Surgical treatment for the unruptured intracranial aneurysm', 'armGroupLabels': ['Surgical treatment']}, {'name': 'Endovascular', 'type': 'PROCEDURE', 'description': 'Endovascular treatment for the unruptured intracranial aneurysm', 'armGroupLabels': ['Endovascular treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029 HUS', 'city': 'Helsinki', 'state': 'Uusimaa', 'country': 'Finland', 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Rahul Raj, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data sharing regulated by the Secondary Use of Health And Social Data Act in Finland.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rahul Raj', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}