An observational study in Unruptured Intracranial Aneurysm and Intracranial Aneurysm Rupture, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Beijing Tiantan Hospital · Observational
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 as moyamoya or arteriovenous malformation, or severe organ dysfunction are excluded. No study-driven intervention is imposed; routine clinical care continues. Baseline data include demographics, hypertension history, laboratory tests, 24-hour ambulatory blood pressure, home blood pressure for 7 days, optional wearable monitoring, and CTA/MRA/DSA for 3D aneurysm parameters such as volume, surface area, compactness, and sphericity. BPV is summarized using standard deviation, coefficient of variation, and variability independent of the mean.Participants scheduled for in-hospital visits provide written informed consent and are followed at 6, 12, 24, 36, 48, 72, 96, and 120 months with repeated BPV measurement and imaging. Participants who already have at least two qualifying imaging and blood-pressure records before enrollment and will not return for in-person visits provide verbal consent and are followed by telephone every 6-12 months to confirm health status and rupture/growth events. All data are entered into a REDCap system with automated and manual quality checks. A historical institutional dataset (CAIASA) may be used only for algorithm pretraining and is not counted as the prospective enrollment target.The primary outcome is UIA rupture confirmed by CT or surgery. Secondary outcomes include aneurysm growth defined as diameter increase ≥1 mm, changes in 3D morphological parameters over time, BPV trends, and incremental predictive performance versus PHASES using AUC, IDI, and NRI with bootstrapping validation. A data safety monitoring committee oversees safety and data integrity. Findings are expected to support individualized follow-up and treatment decisions for people with unruptured aneurysms.
Beijing Tiantan Hospital is the lead sponsor of 483 studies on the registry; 289 are open to participants now.
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Single-center observational population drawn from the outpatient neurovascular clinic, neurology/neurosurgery referral service, and existing CAIASA database at Beijing Tiantan Hospital/Beijing Neurosurgical Institute, China. The source population comprises adults aged 18 to 80 years with one or more unruptured intracranial aneurysms detected by CTA, MRA, or DSA and judged by a neurovascular team to be suitable for conservative observation rather than immediate treatment. Enrolled participants form a prospective longitudinal cohort followed for up to 120 months with 24-hour ambulatory blood pressure, home/wearable blood pressure, repeated aneurysm imaging, and three-dimensional morphometry. The target enrolled population is approximately 2000 prospectively recruited participants between 2025 and 2027. All participants must be able to complete follow-up and consent per the differentiated written/telephone procedure.
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Exclusion Criteria:
Adults 18 to 80 with one or more unruptured intracranial aneurysms confirmed by CTA, MRA, or DSA and selected for conservative observation at Beijing Tiantan Hospital. No prophylactic clipping, coiling, stent-assisted coiling, or flow diversion is performed. Written informed consent is obtained for hospital follow-up; oral consent is permitted for telephone-only follow-up when complete prior imaging and blood pressure data are available. At baseline and 6, 12, 24, 36, 48, 72, 96, and 120 months, hospital participants undergo 24-hour ambulatory blood pressure, home or wearable blood pressure, and repeat CTA/MRA/DSA; three-dimensional morphometry includes volume, surface area, compactness, and sphericity by semi-automated segmentation. All participants have telephone follow-up every 6 to 12 months for rupture, aneurysm growth of at least 1 mm, and adverse events.
Incidence of unruptured intracranial aneurysm rupture confirmed by CT or intraoperative findings
Rupture is defined as subarachnoid hemorrhage or aneurysm bleeding confirmed by non-contrast CT, CT angiography, DSA, or intraoperative findings in participants under conservative observation. Reported as number/percentage of aneurysms or participants with rupture and annualized rupture rate; time-to-event analyzed from enrollment.
Time frame: From enrollment through 6, 12, 24, 36, 48, 72, 96 and 120 months of follow-up, up to 10 years
Aneurysm growth defined as maximal diameter increase of 1 mm or more on serial imaging
Growth is assessed by comparing baseline and follow-up CTA, MRA or DSA measurements of maximal aneurysm diameter. Defined as increase ≥1 mm in any dimension versus baseline. Reported as count/percentage of aneurysms with growth; also analyzed as time-to-growth.
Time frame: Baseline and 6, 12, 24, 36, 48, 72, 96, 120 months; overall up to 10 years
Change in aneurysm volume, surface area, sphericity and compactness from baseline 3D reconstruction
Aneurysm sac is segmented from CTA/MRA/DSA and reconstructed by marching-cubes or equivalent method. Reported as absolute and percent change in volume (mm³), surface area (mm²), sphericity index (dimensionless, 0-1; lower indicates less spherical), and compactness (dimensionless). Each parameter analyzed separately; used to describe structural evolution over time.
Time frame: Baseline and 6, 12, 24, 36, 48, 72, 96, 120 months; overall up to 10 years
Change in systolic and diastolic blood pressure variability measured by SD, coefficient of variation and VIM
BPV derived from 24-hour ambulatory BP (every 30 min 06:00-22:00, every 60 min 22:00-06:00), 7-day home BP, or wearable records when available. For systolic and diastolic BP compute standard deviation, coefficient of variation (SD/mean×100%) and variability independent of mean (VIM). Reported as baseline value and change at each follow-up.
Time frame: Baseline and 6, 12, 24, 36, 48, 72, 96, 120 months; overall up to 10 years
Association of blood pressure variability indices with aneurysm 3D morphological change and growth
Prespecified exploratory-but pre-specified-analysis linking SD/CoV/VIM of systolic/diastolic BP to change in volume, surface area, sphericity, compactness and dichotomous growth ≥1 mm, using longitudinal mixed models or time-series regression. Adjusts for age, hypertension, antihypertensive use, aneurysm size/location. Supports secondary aim on BPV-driven morphological evolution.
Time frame: Baseline and 6, 12, 24, 36, 48, 72, 96, 120 months; overall up to 10 years
Discrimination and reclassification of LSTM and Transformer rupture-risk model versus PHASES score
Using longitudinal BPV, 3D morphology and baseline covariates, train LSTM and Transformer time-series models for rupture risk. Compare against PHASES using area under ROC curve, integrated discrimination improvement and net reclassification improvement with bootstrapping (1000 resamples) internal validation. Reported as model performance metrics, not as a clinical event count.
Time frame: Model development and validation over baseline-to-120-month follow-up dataset; performance reported at study completion
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