NCT04872842

Brief Summary

In this study, 20 regional neurosurgery centers across the country will be included, and the study cohort will be constructed on the basis of the IARP-CP cohort.The artificial intelligence platform was used to analyze the clinical, morphological, hemodynamics, aneurysm wall characteristics and other factors of unruptured aneurysms, as well as the relationship between these factors and the risk of aneurysm instability, seek the potential risk factors, and finally establish a multi-dimensional prediction model of rupture risk of intracranial aneurysms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

April 22, 2021

Last Update Submit

November 7, 2022

Conditions

Intracranial Aneurysm

Keywords

intracranial aneurysmonline registration platformartificial intelligencemultidimensional model

Outcome Measures

Primary Outcomes (1)

  • Aneurysm rupture

    2 years

Secondary Outcomes (1)

  • Aneurysm growth

    2 years

Study Arms (2)

unstable intracranial aneurysms

Unstable intracranial aneurysms are defined as the intracranial aneurysms that grows or ruptures.

Other: Obervation

stable intracranial aneurysms

Stable intracranial aneurysms are defined as the intracranial aneurysms that have no significant morphological changes.

Other: Obervation

Interventions

ObervationOTHER

This study is an observational study without any intervention

stable intracranial aneurysmsunstable intracranial aneurysms

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chinese

You may qualify if:

  • years old;
  • At least one unruptured intracranial aneurysm was found by CTA;
  • No relevant symptoms, receiving non-operative and conservative observation treatment;
  • Signing the informed consent.

You may not qualify if:

  • Other cerebrovascular structural lesions (such as cerebrovascular malformation and arteriovenous fistula) or craniocerebral tumors;
  • Fusiform or dissecting aneurysms;
  • Traumatic, mycotic and atrial myxoma associated aneurysms;
  • Suffering from systemic connective tissue diseases, such as polycystic kidney disease;
  • Expectant survival of no more than 3 years due to other diseases or poor general conditions;
  • Patients refuse to follow up or cannot communicate with them due to mental diseases;
  • Pregnant women or participating in other aneurysm related studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

  • Liu Q, Li J, Zhang Y, Leng X, Mossa-Basha M, Levitt MR, Wang S, Zhu C. Association of calcium channel blockers with lower incidence of intracranial aneurysm rupture and growth in hypertensive patients. J Neurosurg. 2023 Jan 27;139(3):651-660. doi: 10.3171/2022.12.JNS222428. Print 2023 Sep 1.

    PMID: 36708539DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Shuo Wang, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Cerebrovascular Neurosurgery

Study Record Dates

First Submitted

April 22, 2021

First Posted

May 5, 2021

Study Start

September 1, 2021

Primary Completion

March 1, 2022

Study Completion

May 1, 2022

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

Locations

CN(1)