Unruptured Intracranial AneurysmNCT07893574
Prospective Observational Cohort Study for Predicting Unruptured Intracranial Aneurysm Rupture Risk Using Blood Pressure Variability and 3D Structural Evolution
An observational study of Unruptured Intracranial Aneurysm and Intracranial Aneurysm Rupture, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unruptured Intracranial Aneurysm, Intracranial Aneurysm Rupture
- Type of treatment
- Pill or oral medicine
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing
Zihan Yin, +86 15510322942, neuroyinzihan@foxmail.com
About this study
Official title: A Prospective Longitudinal Observational Cohort Study to Develop and Validate a Predictive Model for Unruptured Intracranial Aneurysm Rupture Risk Based on Blood Pressure Variability and Three-Dimensional Structural Dynamic Evolution
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.
- Keywords
- Blood Pressure Variability, Aneurysm Morphology, Longitudinal Cohort, Deep Learning Prediction Model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective conservative UIA BPV and 3D morphometry cohort | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment through 6, 12, 24, 36, 48, 72, 96 and 120 months of follow-up, up to 10 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 6, 12, 24, 36, 48, 72, 96, 120 months; overall up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2037 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unruptured Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893574
- Sponsor's protocol ID
- KY2026-044-02
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Longitudinal Observational Cohort Study to Develop and Validate a Predictive Model for Unruptured Intracranial Aneurysm Rupture Risk Based on Blood Pressure Variability and Three-Dimensional Structural Dynamic Evolution
- ClinicalTrials.gov ID
- NCT07893574
- Acronym / sponsor ID
- KY2026-044-02
- Keywords
- Blood Pressure Variability, Aneurysm Morphology, Longitudinal Cohort, Deep Learning Prediction Model
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2037 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective conservative UIA BPV and 3D morphometry cohort | – | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of unruptured intracranial aneurysm rupture confirmed by CT or intraoperative findings
Time frame: From enrollment through 6, 12, 24, 36, 48, 72, 96 and 120 months of follow-up, up to 10 years
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.
3 secondary outcomes
Aneurysm growth defined as maximal diameter increase of 1 mm or more on serial imaging
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
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
Time frame: Baseline and 6, 12, 24, 36, 48, 72, 96, 120 months; overall up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unruptured Intracranial Aneurysm and Intracranial Aneurysm Rupture, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of unruptured intracranial aneurysm rupture confirmed by CT or intraoperative findings (time frame: From enrollment through 6, 12, 24, 36, 48, 72, 96 and 120 months of follow-up, up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.