Trial · NCT07893574
Prospective Observational Cohort Study for Predicting Unruptured Intracranial Aneurysm Rupture Risk Using Blood Pressure Variability and 3D Structural Evolution
NCT07893574, Recruiting, Beijing Tiantan Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prospective Observational Cohort Study for Predicting Unruptured Intracranial Aneurysm Rupture Risk Using Blood Pressure Variability and 3D Structural Evolution. Trials, record NCT07893574. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07893574
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prospective Observational Cohort Study for Predicting Unruptured Intracranial Aneurysm Rupture Risk Using Blood Pressure Variability and 3D Structural Evolution
- NCT number
- NCT07893574
- Status
- Recruiting
- Enrollment
- 2,000 participants, estimated
- Lead sponsor
- Beijing Tiantan Hospital
- Conditions
- Unruptured Intracranial Aneurysm, Intracranial Aneurysm Rupture
- First posted
- 2026-10-26
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of unruptured intracranial aneurysm rupture confirmed by CT or intraoperative findings | 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. |
| Secondary | Aneurysm growth defined as maximal diameter increase of 1 mm or more on serial imaging | Baseline and 6, 12, 24, 36, 48, 72, 96, 120 months; overall up to 10 years | 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. |
| Secondary | Change in aneurysm volume, surface area, sphericity and compactness from baseline 3D reconstruction | Baseline and 6, 12, 24, 36, 48, 72, 96, 120 months; overall up to 10 years | 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. |
| Secondary | Change in systolic and diastolic blood pressure variability measured by SD, coefficient of variation and VIM | Baseline and 6, 12, 24, 36, 48, 72, 96, 120 months; overall up to 10 years | 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. |
| Other | Association of blood pressure variability indices with aneurysm 3D morphological change and growth | Baseline and 6, 12, 24, 36, 48, 72, 96, 120 months; overall up to 10 years | 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. |
| Other | Discrimination and reclassification of LSTM and Transformer rupture-risk model versus PHASES score | Model development and validation over baseline-to-120-month follow-up dataset; performance reported at study completion | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07893574
GET https://conductscience.org/api/trials/v1/NCT07893574/registered