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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04872842
Other study ID # 82071296
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
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