This is a Registry Study on a Multidimensional Prediction Model for Rupture Risk of Unruptured Intracranial Aneurysms in China
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 500
- Locations
- 12
- Primary Endpoint
- The rupture of intracranial aneurysms
Study Overview
Brief Summary
This is a registry study on a multidimensional prediction model for rupture risk of unruptured intracranial aneurysms in China.
Detailed Description
This subsequent program China Intracranial Aneurysm Project - 2 (CIAP-2) will comprise screening of 500 patients from the UIA cohort (CIAP-1) and focus on hemodynamics factors, high resolution magnetic resonance imaging (HRMRI), genetic factors and biomarkers. Possible risk factors for rupture of UIA, including genetic factors, biomarkers, HRMRI, and hemodynamic will be analyzed. The first project of the China Intracranial Aneurysm Project (CIAP-1: Chaired by the Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi, China) will establish a prospective cohort of 5000 patients with UIA from 20 centers in China, and collect baseline information for each patient. Multidimensional data will be acquired in follow-up assessments. Statistically significant clinical features in the UIA cohort will also be analyzed and integrated into this model for predicting risk of UIA rupture. After the model has been set up, the resultant evidence-based prediction will be used to provide a preliminary theoretical basis for the treatment of aneurysms at high risk of rupture.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 14 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •At least 1 UIA that is untreated and confirmed by imaging: Computed tomography angiography (CTA), magnetic resonance angiography (MRA) and digital subtraction angiography (DSA). Regardless of the presence of clinical symptoms
- •Patient currently has the ability to live independently, and a modified Ranking Score less than or equal to 3 points
- •Older than 14 years of age
- •Patient or relatives agreed to sign the consent form
Exclusion Criteria
- •Subarachnoid hemorrhage of unknown origin
- •Presence of other intracranial vascular malformations, such as cerebral arteriovenous malformation (AVM) or cerebral arteriovenous fistula (AVF)
- •Intracranial and other malignant tumors
- •Fusiform, traumatic, bacterial or dissecting aneurysm
- •Patients with severe mental illness who are unable to communicate
- •Patients with other diseases or poor general condition who are expected to survive less than 1 year
- •Patients with intracranial aneurysms who have joined other similar research institutions
- •Patients who refused follow-up
- •The definition of modified Ranking Score:
- •0 Completely silent
- •1 Despite symptoms, but not visibly disabled, can complete all regular duties and activities
- •2 Mild disabilities, not all activities previously possible, but can deal with personal affairs without need of assistance
- •3 Moderate disability requires some help, but walking does not need assistance;
- •4 Severe disabilities, unable to walk independently, no others can not meet their needs
- •5 Severely disabled, bedridden, Urine, requiring continuous care and care;
- •6 Mortality
Outcomes
Primary Outcomes
The rupture of intracranial aneurysms
Time Frame: Up to 12 months or time of aneurysm repair surgery
The rupture of unruptured intracranial aneurysms.
Secondary Outcomes
- Changes in morphology of unruptured intracranial aneurysms(Up to 12 months or time of aneurysm repair surgery)
Investigators
Xinjian Yang, MD
Vice Chair of Department of Interventional Neuroradiology of Beijing Neurosurgical Institute
Beijing Neurosurgical Institute