Clinical trial NCT04872842: Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on 100 Regional Medical Centers in China and Population Follow-up Study
Official title: Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on 100 Regional Medical Centers in China and Population Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Keywords: intracranial aneurysm
online registration platform
artificial intelligence
multidimensional model
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Hospital
name: Peking University Third Hospital
name: Beijing Sanbo Brain Hospital
name: Beijing Chao Yang Hospital
name: Binzhou Renmin Hospital
name: Fujian Medical University Union Hospital
name: First Affiliated Hospital of Fujian Medical University
name: Guangzhou Red Cross Hospital
name: The First Affiliated Hospital of Haerbin Medical University
name: The Affiliated Hospital of Qingdao University
name: Shanxi Provincial People's Hospital
name: Beijing Tsinghua Changgeng Hospital
name: RenJi Hospital
name: Sichuan Provincial People's Hospital
name: Wuhan Union Hospital, China
name: The Affiliated Hospital of Kunming Medical University
name: Beijing Unimed Technology Company
First posted: 2021-05-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Aneurysm rupture
timeFrame: 2 years
Secondary outcomes:
measure: Aneurysm growth
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Shuo Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: