Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-03-02 @ 4:22 PM
Study NCT ID:
NCT06539767
Status:
RECRUITING
Last Update Posted:
2025-07-28
First Post:
2024-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Assessment and Mechanism Analysis of Intracranial Multiple Aneurysm Instability Based on High-resolution Magnetic Resonance, Imaging Histology and Hemodynamics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2024-06-04', 'studyFirstSubmitQcDate': '2024-08-01', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High resolution MRI aneurysm features', 'timeFrame': '1 year', 'description': 'Enhancement grade was defined as follows: grade 0 for none enhancement, grade 1 for focal enhancement, involved the neck, the intermediate portion, the dome, or a bleb;grade 2 for thin annular enhancement (maximum thicknessā¤1 mm) , grade 3 for thick annular enhancement(maximum thickness\\>1 mm) .'}], 'secondaryOutcomes': [{'measure': 'postoperative mRS score', 'timeFrame': '1 year', 'description': "MRS score definition: The MRS score, also known as the Modified Rankin Scale, is a scale used to evaluate the neurological recovery status of stroke patients. It is divided into seven levels, Level 0: completely asymptomatic. Level 1: Despite symptoms, without obvious disabilities, able to complete all frequently engaged work and activities.\n\nLevel 2: Mild disability, unable to complete all work and activities, but able to handle personal affairs without the need for assistance from others.\n\nLevel 3: Moderate disability, requiring assistance from others to walking without assistance.\n\nLevel 4: Severe disability, unable to walk without the help of others, unable to take care of one's own needs.\n\nLevel 5: Severe disability, bedridden, urinary and fecal incontinence, requiring continuous care, and requiring multiple 24-hour care from others.\n\nLevel 6: Death. The higher the mRS score, the worse the patient's prognosis."}, {'measure': 'postoperative aneurysm occlusion rate', 'timeFrame': '1 year', 'description': 'Raymond classification, grade I: complete embolism; Grade II: residual aneurysm neck;'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arterial Aneurysm Wall Enhancement on HRMRI']}, 'descriptionModule': {'briefSummary': 'This project proposes to establish a prospective cohort of MIA based on a preexisting multicenter MIA database and to combine multidimensional methods such as high-resolution magnetic resonance, hemodynamics, ambulatory blood pressure, and imaging histology to study aneurysm instability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Inclusion Criteria:\n\n1\\. be older than 18 years of age; 2. complete a high-resolution magnetic resonance exam\n\nExclusion Criteria:\n\n1\\. aneurysm combined with other cerebrovascular diseases; 2. substandard image quality', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80 years old, male or infertile female;\n* Diagnosed as IA (intracranial aneurysm) through CTA, MRA, or DSA; And it is suitable for endovascular intervention treatment\n* The patient and/or their legal representative or guardian fully understand the research purpose, voluntarily participate and sign informed consent Books;\n* Patients willing to cooperate with high-resolution magnetic resonance imaging.\n* Patients willing to follow up and evaluate according to clinical research protocol requirements\n\nExclusion Criteria:\n\n* AVM (arteriovenous malformation), Moyamoya disease, or DAVF (dural arteriovenous fistula) related aneurysms;\n* Patients with contraindications for high-resolution magnetic resonance imaging;\n* Participants in clinical trials of other drugs or medical devices;\n* Patients with severe underlying diseases and extremely poor clinical conditions who cannot tolerate general anesthesia surgery;\n* Patients with poor compliance and inability to cooperate with follow-up;\n* Possible or clear history of severe allergy to contrast agents;\n* Patients with a life expectancy of less than 2 years;\n* Women who are breastfeeding and preparing for pregnancy during the study period'}, 'identificationModule': {'nctId': 'NCT06539767', 'briefTitle': 'Risk Assessment and Mechanism Analysis of Intracranial Multiple Aneurysm Instability Based on High-resolution Magnetic Resonance, Imaging Histology and Hemodynamics', 'organization': {'class': 'OTHER', 'fullName': 'Zhujiang Hospital'}, 'officialTitle': 'Risk Assessment and Mechanism Analysis of Intracranial Multiple Aneurysm Instability Based on High-resolution Magnetic Resonance, Imaging Histology and Hemodynamics', 'orgStudyIdInfo': {'id': '2023-KY-127-01'}}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chuanzhi Duan', 'role': 'CONTACT', 'email': 'doctor_duan@163.com', 'phone': '15536363897'}], 'facility': 'Zhujiang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xin feng', 'role': 'CONTACT', 'email': '13681134001@163.com', 'phone': '13681134001@163.com'}], 'facility': 'Southern medical university, zhujiang hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhujiang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}