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

Intracranial Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04872842
• Other study ID #: 82071296
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: November 2022
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: May 1, 2022
• Est. primary completion date: March 1, 2022
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Other:
• Obervation
This study is an observational study without any intervention

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (18)

Lead Sponsor

Collaborator

Beijing Tiantan Hospital

Beijing Chao Yang Hospital, Beijing Hospital, Beijing Sanbo Brain Hospital, Beijing Tsinghua Changgeng Hospital, Beijing Unimed Technology Company, Binzhou Renmin Hospital, First Affiliated Hospital of Fujian Medical University, Fujian Medical University Union Hospital, Guangzhou Red Cross Hospital, Peking University Third Hospital, RenJi Hospital, Shanxi Provincial People's Hospital, Sichuan Provincial People's Hospital, The Affiliated Hospital of Kunming Medical University, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Haerbin Medical University, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aneurysm rupture		2 years
Secondary	Aneurysm growth		2 years