Predicting unruptured brain aneurysm rupture risk with blood pressure variability and 3D changes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective, longitudinal observational cohort of adults with UIAs kept under conservative management. The study collects time-series data on blood pressure variability and 3D aneurysm morphology, then develops deep learning models (LSTM and Transformer) to predict rupture risk. It also compares model predictions with traditional risk scores such as PHASES and examines links between BPV and aneurysm evolution. Enrollment is consecutive for eligible patients aged 18-80 confirmed by CTA, MRA, or DSA, with follow-up imaging and BP monitoring planned over multiple time points.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Tiantan Hospital, Capital Medical University
  Beijing, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.