Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on 100 Regional Medical Centers in China and Population Follow-up Study

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.

Study Overview

• Status: Completed
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Other: Obervation

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing TianTan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chinese

Description

Inclusion Criteria:

1. 18-75 years old;
2. At least one unruptured intracranial aneurysm was found by CTA;
3. No relevant symptoms, receiving non-operative and conservative observation treatment;
4. Signing the informed consent.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
unstable intracranial aneurysms; Unstable intracranial aneurysms are defined as the intracranial aneurysms that grows or ruptures.	Other: Obervation; This study is an observational study without any intervention
stable intracranial aneurysms; Stable intracranial aneurysms are defined as the intracranial aneurysms that have no significant morphological changes.	Other: Obervation; This study is an observational study without any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Aneurysm rupture	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Aneurysm growth	2 years

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: Peking University Third Hospital; RenJi Hospital; Beijing Sanbo Brain Hospital; First Affiliated Hospital of Fujian Medical University; The Affiliated Hospital of Qingdao University; Beijing Chao Yang Hospital; Beijing Hospital; Wuhan Union Hospital, China; Fujian Medical University Union Hospital; Sichuan Provincial People's Hospital; Guangzhou Red Cross Hospital; Beijing Tsinghua Changgeng Hospital; Shanxi Provincial People's Hospital; Binzhou Renmin Hospital; The First Affiliated Hospital of Haerbin Medical University; The Affiliated Hospital of Kunming Medical University; Beijing Unimed Technology Company
• Investigators: Principal Investigator: Shuo Wang, MD, Beijing TianTan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: artificial intelligence; intracranial aneurysm; online registration platform; multidimensional model
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: 82071296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No