💬In plain words
What the trial is, and whether it could suit you
This is a single-center, prospective, longitudinal observational cohort study in adults with unruptured intracranial aneurysms (UIAs) who are managed by conservative observation rather than immediate surgery or endovascular treatment. The study aims to build a time-series dataset combining blood pressure variability (BPV) and three-dimensional (3D) aneurysm morphological evolution, and to develop deep-learning models using long short-term memory (LSTM) and Transformer networks to predict aneurysm rupture risk. A secondary aim is to compare the new models with traditional scores such as PHASES and to explore how BPV relates to 3D aneurysm change.Participants aged 18-80 years with UIA confirmed by CTA, MRA, or DSA and judged suitable for conservative follow-up will be enrolled consecutively at the study site. Those with imaging contraindications, other major cerebrovascular diseases such a
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📋 Eligibility rules (as published)
Inclusion Criteria:
* Age 18 to 80 years at enrollment.
* Diagnosis of one or more unruptured intracranial aneurysms confirmed by CT angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA).
* Managed by conservative observation (no prophylactic clipping, coiling, stent-assisted coiling, or flow diversion) as decided by the treating neurovascular team.
* Able and willing to undergo repeated blood pressure variability assessment and imaging follow-up, including 24-hour ambulatory blood pressure and CTA/MRA/DSA as clinically indicated.
* Provides written informed consent if planning in-hospital follow-up, or oral informed consent if only telephone follow-up and prior complete data are available per protocol.
* For participants without preexisting repeat imaging and blood pressure data, willing to attend hospital follow-up at 6, 12, 24, 36, 48, 72, 96, and 120 months; all participants agree to telephone follow-up every 6 to 12 months.
Exclusion Criteria:
* Known allergy to iodinated contrast or other contraindications preventing CTA/DSA, or contraindications to MRA/contrast preventing required imaging.
* Severe renal impairment, contraindicated for required contrast-enhanced imaging per investigator judgment.
* Other clinically significant cerebrovascular diseases that confound aneurysm natural history, including moyamoya disease, arteriovenous malformation, arteriovenous fistula, or symptomatic intracranial stenosis.
* Dissecting, traumatic, mycotic, or tumor-associated aneurysms, or aneurysms secondary to infective/inflammatory arteriopathy.
* Severe hepatic, cardiac, renal, respiratory, hematologic, or other systemic organ dysfunction that would preclude follow-up or bias blood pressure/imaging data.
* Expected survival less than 6 months due to non-cerebral disease.
* Inability to provide informed consent, inability to communicate, severe psychiatric disease, or no available telephone/contact for follow-up.
* Already enrolled in another UIA interventional trial that prohibits concurrent observation registration, or prior prophylactic treatment of all enrolled aneurysms.
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